AccessGUDID - DEVICE: WasherCap™ Countersink 10mm (08437019739645)

GUDID

Device Identifier (DI) Information

Brand Name: WasherCap™ Countersink 10mm
Version or Model: 21
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ABANZA TECNOMED SL.

Primary DI Number: 08437019739645
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 465714287 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16462	Surgical countersink, reusable	A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWW	Countersink

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e807db5a-7dd2-4bb8-8e0d-b593c038cd44
Public Version Date: June 09, 2023
Public Version Number: 1
DI Record Publish Date: June 01, 2023