AccessGUDID - DEVICE: Integra® (10381780236818)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: TRL71503T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TRL-715-03T
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780236818
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 Lunate Trial is used to evaluate the size and fit of the implant.

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?
61047	Carpometacarpal interpositional spacer prosthesis trial	A sterile copy of a final carpometacarpal interpositional spacer 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 one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWN	PROSTHESIS, WRIST, CARPAL LUNATE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080997	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: 7.9 in L x 3.1 in W Handle

Device Record Status

Public Device Record Key: e000e7c1-d36e-416c-b680-11f3bc9b3e8e
Public Version Date: February 24, 2023
Public Version Number: 8
DI Record Publish Date: August 15, 2016