AccessGUDID - DEVICE: PROMOS (07611996037913)

GUDID

Brand Name: PROMOS
Version or Model: 75006528
Catalog Number: 75006528
Company Name: Smith & Nephew, Inc.

Primary DI Number: 07611996037913
Issuing Agency: GS1
Device Count: 1

Device Description: PROMOS TRIAL GLENOID 2-26

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Shoulder glenoid fossa trial prosthesis	A copy of a final shoulder glenoid fossa prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is cup-like in shape and typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Product Code	Product Code Name
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling
No storage/handling found

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: November 25, 2015
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(800)238-7538
Email: GUDID@SMITH-NEPHEW.COM