AccessGUDID - DEVICE: TOGGLELOC WITH ZIPLOOP (00880304464773)

GUDID

Device Identifier (DI) Information

Brand Name: TOGGLELOC WITH ZIPLOOP
Version or Model: 909848
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 909848
Company Name: Biomet Sports Medicine, LLC

Primary DI Number: 00880304464773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627100159 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
47138	Ligament reconstruction instrument set, reusable	A collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MBI	FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
JDR	STAPLE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130033	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 77aa34da-bbe7-4b9d-9e75-d4378a0d2dad
Public Version Date: June 25, 2025
Public Version Number: 6
DI Record Publish Date: October 24, 2015