AccessGUDID - DEVICE: Instrument Kit: Fractured Abutment/ Screw USA (07340152102027)

GUDID

Device Identifier (DI) Information

Brand Name: Instrument Kit: Fractured Abutment/ Screw USA
Version or Model: 2533
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Integrum AB

Primary DI Number: 07340152102027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 356739813 *Terms of Use

Device Description: The intended purpose of the Fractured Abutment / Abutment Screw kit is, by an Integrum certified physician to perform extraction of a fractured Abutment remnant in the Fixture of the OPRA™ Implant, and the extraction of a femur fractured Abutment Screw when the fracture has occurred in one of the threads of the OPRA™ Implant Abutment screw. T-Handle 5mm Socket M9 Guide Pin Rescue Drill Bit Holder Drill / Torx Guide Allen Key 2.5 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:	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?
58743	Internal-external leg prosthesis osseointegration bar	A rod with a screw-like or press-fit design intended to be implanted into the residual bone of a lower limb (e.g., femur, tibia) after amputation to function as an anchoring fixture and stabilizing bar for the connection of an internal-external leg prosthesis. It is designed to project beyond the bone but not through the skin so that a protruding trans-stomal connector/abutment can be attached to its distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PJY	Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P190009	003

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
No Device Sizes

Device Record Status

Public Device Record Key: 5727fd84-2f91-43b6-80f4-62dc93f8aa77
Public Version Date: September 13, 2024
Public Version Number: 2
DI Record Publish Date: July 25, 2023