JuggerKnot Soft Anchor SSI003405

GUDID 00880304858961

Biomet Orthopedics, LLC

Surgical drill guide, reusable
Primary Device ID00880304858961
NIH Device Record Key2e683e98-ca5d-4811-9d24-bdbb3e957493
Commercial Distribution StatusIn Commercial Distribution
Brand NameJuggerKnot Soft Anchor
Version Model NumberSSI003405
Catalog NumberSSI003405
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304858961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304858961]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2017-02-16

On-Brand Devices [JuggerKnot Soft Anchor]

00880304858985SSI002542
00880304858978SSI002297
00880304858961SSI003405
00880304858954SSI003404

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.