AccessGUDID - DEVICE: BioTritis (10884521513532)

GUDID

Device Identifier (DI) Information

Brand Name: BioTritis
Version or Model: 2146SS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521513532
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 10 mm Fixation Washer and Trocar Tip Drill/Drill Guide

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?
45040	Meniscus screw	A small, threaded, bioabsorbable rod intended to be used for the internal fixation of vertical lesions located in the vascularized area of the meniscus (a crescent-shaped disk of fibrocartilage that borders and partly covers the articulating surfaces of the tibia and femur at the knee). It is typically cannulated for guided percutaneous insertion. The device is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 12 Millimeter
Length: 38 Millimeter

Device Record Status

Public Device Record Key: f24f4a85-cc03-4fbb-8737-8c0c4202083d
Public Version Date: June 24, 2025
Public Version Number: 9
DI Record Publish Date: September 24, 2016