AccessGUDID - DEVICE: SHOULDER INNOVATIONS TSA SYSTEM (B1130S1IC000000)

GUDID

Device Identifier (DI) Information

Brand Name: SHOULDER INNOVATIONS TSA SYSTEM
Version or Model: INSTRUMENT CASE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0S1IC00000
Company Name: Shoulder Innovations, Inc.

Primary DI Number: B1130S1IC000000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080404519 *Terms of Use

Device Description: No description.

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?
13730	Device sterilization/disinfection container, reusable	A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: a7485aa5-7c46-4ff2-8bc4-5078c801f24a
Public Version Date: April 04, 2023
Public Version Number: 5
DI Record Publish Date: June 30, 2018