Positioner Guide

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

Positioner Guide

UDI-DI code

08437019739348

Basic UDI-DI

B-08437019739348

Reference / catalog number

ATMWCIN79

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 that is placed on the positioner (once it has been introduced into the tunnel) to pass a Ø2.4 mm Kirschner wire through it that will serve to guide the countersink of the cortex.

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.

• L091104ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification