WasherCap™ Countersink 8mm

Organization name

ABANZA TECNOMED, S.L.

SRN

ES-MF-000007530

Manufacturer status

Active

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.

Primary placement in Spain; available across 1 country total.

Trade name

WasherCap™ Countersink 8mm

UDI-DI code

08437019739621

Basic UDI-DI

B-08437019739621

Reference / catalog number

ATMWCIN07

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Cannulated instrument used to shape the bone cortex to place de cap of the WasherCap™ Fixation System correctly. The countersink is composed by two parts (the stop and the body). Both parts must be assembled to compose the countersink to ensure that it can be used in accordance with its intended use. The countersink need to be disassembled during its reprocessing in order to facilitate the cleaning process. Prior to the steriliation process, both parts should be assembled again in order to prepare the countersink for its next use.

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.

• L091102ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE

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