AccessGUDID - DEVICE: Fixture Removal Trephine and Guide Sleeve Kit 25 mm (07340152101792)

GUDID

Device Identifier (DI) Information

Brand Name: Fixture Removal Trephine and Guide Sleeve Kit 25 mm
Version or Model: 2549
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Integrum AB

Primary DI Number: 07340152101792
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 356739813 *Terms of Use

Device Description: The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture. The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone.

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

[?]

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: d2855454-7149-470a-914f-62e4b6b6f792
Public Version Date: September 13, 2024
Public Version Number: 2
DI Record Publish Date: July 28, 2023