AccessGUDID - DEVICE: OPRA Implant System (07340152100665)

GUDID

Device Identifier (DI) Information

Brand Name: OPRA Implant System
Version or Model: 1961
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1961
Company Name: Integrum AB

Primary DI Number: 07340152100665
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 356739813 *Terms of Use

Device Description: Healing Washer 17x0,5 mm

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:	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Leg internal-external prosthesis intrafemoral bar	A sterile rod designed to be implanted into the intramedullary canal of the residual femur after transfemoral (above-the-knee) amputation to function as a stabilizing bar for the connection of a specialized external prosthesis. It is designed to project beyond the femur but not through the skin so that a transcutaneous adaptor can be attached to the distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration), and is available in a variety of diameters and lengths.

GMDN Preferred Term Name

GMDN Definition

Leg internal-external prosthesis intrafemoral bar

A sterile rod designed to be implanted into the intramedullary canal of the residual femur after transfemoral (above-the-knee) amputation to function as a stabilizing bar for the connection of a specialized external prosthesis. It is designed to project beyond the femur but not through the skin so that a transcutaneous adaptor can be attached to the distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration), and is available in a variety of diameters and lengths.

FDA Product Code

[?]

Product Code	Product Code Name
PJY	Transfemoral Percutaneous Prosthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H080004	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation 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: 3f61cb0f-05e9-452d-bc5a-54309cc9a53a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 17, 2016