AccessGUDID - DEVICE: Integra® First Choice® (10381780236757)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® First Choice®
Version or Model: TRL600MED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TRL-600-MED
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780236757
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: The Modular Ulnar Head Collar trial attaches to a trial stem to adapt for a medium or long osteotomy and simulate actual implant stem.

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?
46479	Surgical implant template, reusable	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXE	PROSTHESIS, WRIST, HEMI-, ULNAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112481	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: .622 in H x .472 in dia

Device Record Status

Public Device Record Key: 85f4daf8-446c-465a-ae55-905ea1312886
Public Version Date: February 24, 2023
Public Version Number: 7
DI Record Publish Date: August 15, 2016