AccessGUDID - DEVICE: Integra® (10381780236443)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: TRL35224S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TRL-352-24S
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780236443
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: Modular Radial Head MRH Head Trial Sz. 24S

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?
58750	Elbow humerus prosthesis trial	A copy of a final humerus prosthesis designed to be used for trial reductions during elbow arthroplasty to judge the correct size, length, condyle positioning, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes and 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
KWI	PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032686	000

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
Device Size Text, specify: .945 in dia x .502 in H

Device Record Status

Public Device Record Key: 2360678a-8052-46ed-b93c-e5be0c22ee58
Public Version Date: January 25, 2023
Public Version Number: 7
DI Record Publish Date: August 15, 2016