AccessGUDID - DEVICE: Stabilis (00846832005093)

GUDID

Device Identifier (DI) Information

Brand Name: Stabilis
Version or Model: AFPK20150
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AFPK20150
Company Name: TORNIER, INC.

Primary DI Number: 00846832005093
Issuing Agency: GS1
Commercial Distribution End Date: November 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 968990812 *Terms of Use

Device Description: K-WIRE

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":	Yes
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?
47900	Orthopaedic implant calibration pin	A cylindrical rod used preoperatively as a precision guide to align an orthopaedic implant aiming arm with, e.g., an intramedullary bone nail (femoral, humeral, and tibial) that will be implanted. It is inserted through the guiding locking holes of the adjustable aiming arm and its profiled distal tip is engaged into the locking holes of the intramedullary nail providing a given reference point whereby the drill guides and the rest of the aiming arm can be correctly set to correspond with the holes and measurements of the implant. It is typically made of high-grade stainless steel or synthetic materials. Several calibration pins will be used for this procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic manual surgical instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Outer Diameter: 2 Millimeter
Length: 150 Millimeter

Device Record Status

Public Device Record Key: 3517c6ab-1954-4c8f-9fb0-e74e6ade0497
Public Version Date: August 30, 2023
Public Version Number: 2
DI Record Publish Date: August 10, 2022