Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

WasherCap™ Countersink Positioner… — Class I MDD

MD Atlas
ABANZA TECNOMED, S.L.

EUDAMED last updated this device on Jun 1, 2023

WasherCap™ Countersink Positioner 8mm

B-08437019739676

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ABANZA TECNOMED, S.L.
UDI-DI code: 08437019739676
Reference / catalog number: ATMWCIN81

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: ABANZA TECNOMED, S.L.
SRN: ES-MF-000007530
Manufacturer status: Active

Related devices

Inserter Coupling Screw 7mm & 8mmB-08437019739553On the market Awl 7mm & 8mmB-08437019739515On the market Awl 9mm & 10mmB-08437019739539On the market Countersink Tool8437019739ATMWCIN7836On the market Handle with AO connection sytem8437019739ATMWCIN452POn the market

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW999
The instruments of the WasherCap™ Surgical Instrument Set should be only handled by trauma surgeons who are familiar with the clinical use, surgical technique, proper selection and placement of the WasherCap™ device and the use of it associated Surgical Instrument Set.
CW999
The instruments of the WasherCap™ Surgical Instrument Set are supplied non-sterile and must be reprocessed (cleaned and sterilized) before use. For this purpose, it is recommended to follow the instructions cited in these Instructions for Use and in the document “Reprocessing Instructions” (CI-001) provided by ABANZA with the Surgical Instrument Set.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	May 1, 2023	Dec 31, 2028

Device identification

Trade name: WasherCap™ Countersink Positioner 8mm
UDI-DI code: 08437019739676
Basic UDI-DI: B-08437019739676
Reference / catalog number: ATMWCIN81
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Instrument that is inserted into the tunnel to perpendicularly position the “positioning guide” element in order to facilitate cortical shaping.
Additional information URL: https://abanzamed.com/wp-content/uploads/2023/01/001-02-02-INS.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L091101ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.