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

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Organization name
UDI-DI code
Reference / catalog number

Countersink Tool — Class I MDR by ABANZA TECNOMED, S.L.

MD Atlas
ABANZA TECNOMED, S.L.

EUDAMED last updated this device on Jun 1, 2023

Countersink Tool

8437019739ATMWCIN7836

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ABANZA TECNOMED, S.L.
UDI-DI code: 08437019739331
Reference / catalog number: ATMWCIN78

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Manufacturer information

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

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	Jan 28, 2026

Device identification

Trade name: Countersink Tool
UDI-DI code: 08437019739331
Basic UDI-DI: 8437019739ATMWCIN7836
Reference / catalog number: ATMWCIN78
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Tool used to thread and unscrew the top of the countersink body for easy disassembly.
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)

L098099ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES

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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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.