AccessGUDID - DEVICE: Sub-Coracoid Clip - Small, Rectangle, Curved (G523T1005260)

GUDID

Device Identifier (DI) Information

Brand Name: Sub-Coracoid Clip - Small, Rectangle, Curved
Version or Model: T100526
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Cc-Instruments Inc.

Primary DI Number: G523T1005260
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119059465 *Terms of Use

Device Description: Sub-Coracoid Clip - Small, Rectangle, Curved

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:	Yes
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?
62000	Acromioclavicular joint stabilization implant	A sterile implantable device intended to be used to approximate/stabilize the acromioclavicular joint to facilitate healing of a disrupted coracoclavicular ligament (i.e., the device is not intended to replace the damaged ligament). It is in the form of a cord with a loop for attachment to the coracoid process at one end, with a component for fixation to the clavicle (e.g., screw) at the other end. It may be implanted arthroscopically or during open surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTN	Washer, Bolt Nut

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232780	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Millimeter

Device Record Status

Public Device Record Key: 549ee7fd-a75f-462c-89f8-daae1c5ac578
Public Version Date: January 23, 2025
Public Version Number: 2
DI Record Publish Date: November 15, 2024