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Organization name
UDI-DI code
Reference / catalog number

Awl 9mm & 10mm — Class I MDD by ABANZA TECNOMED, S.L.

MD Atlas
ABANZA TECNOMED, S.L.

EUDAMED last updated this device on Jun 1, 2023

Awl 9mm & 10mm

B-08437019739539

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ABANZA TECNOMED, S.L.
UDI-DI code: 08437019739539
Reference / catalog number: ATMWCIN44

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Manufacturer information

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

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.

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: Awl 9mm & 10mm
UDI-DI code: 08437019739539
Basic UDI-DI: B-08437019739539
Reference / catalog number: ATMWCIN44
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: Used to insert the screw of the WasherCap™ Fixation System.
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)

L091199ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER

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

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