AccessGUDID - DEVICE: Catalyst CSR Shoulder System (00851388006104)

GUDID

Device Identifier (DI) Information

Brand Name: Catalyst CSR Shoulder System
Version or Model: 1226-7200-005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CATALYST ORTHOSCIENCE INC.

Primary DI Number: 00851388006104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079702565 *Terms of Use

Device Description: Humeral Implant, Size E

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?
48089	Resurfacing humeral head prosthesis	A sterile implantable device designed to treat a disease-damaged (e.g., arthritic) shoulder joint by replacing the humeral articulating surface of the joint while preserving the natural humerus. It consists of a metallic humeral cap [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] that is placed over (resurfaces) a surgically-prepared humeral head, and may be used with a cementless stem.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152825	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
No Device Sizes

Device Record Status

Public Device Record Key: 6b51fe9b-a362-4db3-a41c-706dada38e07
Public Version Date: July 20, 2018
Public Version Number: 4
DI Record Publish Date: July 25, 2016