AccessGUDID - DEVICE: Titan™ Reverse Shoulder System (10381780121657)

GUDID

Device Identifier (DI) Information

Brand Name: Titan™ Reverse Shoulder System
Version or Model: GLS096002E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GLS-0960-02E
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780121657
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: Eccentric Glenosphere is used in the Titan™ Reverse Shoulder System to allow for optimal soft tissue tensioning, maximize stability, increase range of motion and minimize scapular notching.

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?
48093	Reverse shoulder prosthesis head	A sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130050	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
Device Size Text, specify: 1.012 in H; Size 2mm

Device Record Status

Public Device Record Key: 0f5e6f77-9b09-4fde-8374-83bcd94d6f84
Public Version Date: January 25, 2023
Public Version Number: 5
DI Record Publish Date: October 09, 2017