AccessGUDID - DEVICE: Integra® (10381780235002)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: MRADHDINSTP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780235002
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arthroplasty is intended for resurfacing of the 1st metatarsal head or the base of the proximal phalanx. The total arthroplasty is intended for resurfacing of the base of the 1st metatarso-phalangeal joint. This set includes metatarsal, proximal phalanx hemi, and proximal phalanx total trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.

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:	Yes
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?
44758	General external orthopaedic fixation system implantation kit, reusable	A collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.	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: 21.9 in L x 10.1 in W x 2.3 in H

Device Record Status

Public Device Record Key: daa913e9-30f1-4c64-9769-a604f07065a8
Public Version Date: May 02, 2023
Public Version Number: 4
DI Record Publish Date: August 15, 2016