AccessGUDID - DEVICE: Countersink (10855068008218)

GUDID

Device Identifier (DI) Information

Brand Name: Countersink
Version or Model: CCB-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CCB-001
Company Name: Curvafix Inc

Primary DI Number: 10855068008218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039779098 *Terms of Use

Device Description: A manual rotary tool used to enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant.

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
HWC	Screw, Fixation, Bone
HSB	Rod, Fixation, Intramedullary And Accessories

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: 69854c31-ada4-4e1c-8155-fa8a164b49e9
Public Version Date: August 01, 2023
Public Version Number: 2
DI Record Publish Date: August 11, 2021