AccessGUDID - DEVICE: LIGAFIX (03760154006002)

GUDID

Device Identifier (DI) Information

Brand Name: LIGAFIX
Version or Model: Drill bit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LIG9085289
Company Name: S.B.M

Primary DI Number: 03760154006002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 772462123 *Terms of Use

Device Description: LIGAFIX long flute, cannulated drill bit for use with LIGAFIX interference screws for ACL reconstruction.

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?
11332	Cannulated surgical drill bit, reusable	A shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTW	Bit, Drill

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: 8.5 Millimeter
Length: 60 Millimeter

Device Record Status

Public Device Record Key: 3a37e689-692f-4601-855f-b3d7c530f49a
Public Version Date: December 28, 2023
Public Version Number: 1
DI Record Publish Date: December 20, 2023