AccessGUDID - DEVICE: Catalyst CSR Shoulder System (00851388006876)

GUDID

Device Identifier (DI) Information

Brand Name: Catalyst CSR Shoulder System
Version or Model: 1227-5107-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CATALYST ORTHOSCIENCE INC.

Primary DI Number: 00851388006876
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079702565 *Terms of Use

Device Description: 3-Peg Sizing Template, 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?
60932	Shoulder glenoid fossa prosthesis trial	A copy of a final shoulder glenoid fossa prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is cup-like in shape and typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	Active	false

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 [?]
K173812	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
Special Storage Condition, Specify: Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extreme temperature and humidity.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 81709a99-73cf-47f3-b700-dbca7b767458
Public Version Date: February 07, 2019
Public Version Number: 2
DI Record Publish Date: October 22, 2018