SHOULDER INNOVATIONS TSA SYSTEM

Basic Information

• Brand Name: SHOULDER INNOVATIONS TSA SYSTEM
• Primary DI: B1132N1AB00003
• Version / Model: InSet Plus Case Base
• Catalog Number: 2N1AB00003
• Company Name: Shoulder Innovations, Inc.
• Labeler DUNS: 080404519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-08
• Public Version: 4
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: d7807ff6-fadf-4f86-977e-6eafbb2a8f1a

Device Description

Instrument Case Base, original Shoulder Innovations case base modified to hold InSet Plus glenoid trials

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	888.3660	2
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	888.3650	2
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	888.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B1132N1AB00003	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]