AccessGUDID - DEVICE: PROMOS (07611996086447)

GUDID

Device Identifier (DI) Information

Brand Name: PROMOS
Version or Model: 75006655
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 75006655
Company Name: Smith & Nephew, Inc.

Primary DI Number: 07611996086447
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: PROMOS TRIAL HEAD R28/+4

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?
58784	Humeral head prosthesis trial, reusable	A copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: ff4d2ce4-fa60-494f-ad27-666a42dd827d
Public Version Date: September 07, 2023
Public Version Number: 5
DI Record Publish Date: November 25, 2015