AccessGUDID - DEVICE: CSR Shoulder System (00811596030148)

GUDID

Device Identifier (DI) Information

Brand Name: CSR Shoulder System
Version or Model: 1227-4125-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CATALYST ORTHOSCIENCE INC.

Primary DI Number: 00811596030148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079702565 *Terms of Use

Device Description: 3-Peg Augment Trial - 10°, Size: Small

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?
36259	Shoulder glenoid fossa prosthesis, prefabricated	An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191811	000

Device Exempt from Premarket Submission: No 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: 395d7726-d1f7-44d5-b837-f230e71da692
Public Version Date: December 23, 2019
Public Version Number: 2
DI Record Publish Date: September 19, 2019