AccessGUDID - DEVICE: SMR TT Hybrid Glenoid (08033390121606)

GUDID

Device Identifier (DI) Information

Brand Name: SMR TT Hybrid Glenoid
Version or Model: 1379.59.130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1379.59.130
Company Name: LIMACORPORATE SPA

Primary DI Number: 08033390121606
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432066322 *Terms of Use

Device Description: TT Hybrid Glenoid Baseplate Small - Peg L

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?
36259	Shoulder glenoid fossa prosthesis, prefabricated	An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PHX	Shoulder Prosthesis, Reverse Configuration
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163397	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: Small - Peg L

Device Record Status

Public Device Record Key: 8c453daf-0455-48f2-b19f-cebac8448907
Public Version Date: December 23, 2019
Public Version Number: 5
DI Record Publish Date: July 05, 2017