AccessGUDID - DEVICE: Arthrex® (00888867229655)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: AR-9544-19RCAT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AR-9544-19RCAT
Company Name: ARTHREX, INC.

Primary DI Number: 00888867229655
Issuing Agency: GS1
Commercial Distribution End Date: February 25, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: Revers Trial CA Head, 44/19

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?
60931	Reverse shoulder head prosthesis trial	A copy of a final reverse shoulder prosthesis head 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 hemisphere-shaped (glenosphere) and 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
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 9f806647-c5f6-4280-840b-b647a2c77e91
Public Version Date: December 16, 2024
Public Version Number: 7
DI Record Publish Date: February 15, 2017