BONE MULCH CP550800

GUDID 00880304116511

Biomet Sports Medicine, LLC

Ligament bone anchor
Primary Device ID00880304116511
NIH Device Record Keyf8769dd5-4c2b-46a5-a2ac-cbaa35c3d709
Commercial Distribution StatusIn Commercial Distribution
Brand NameBONE MULCH
Version Model NumberCP550800
Catalog NumberCP550800
Company DUNS627100159
Company NameBiomet Sports Medicine, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304116511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-08
Device Publish Date2015-10-24

On-Brand Devices [BONE MULCH]

00880304409033907330
00880304409019907325
00880304408982907320
00880304408975907317
00880304116511CP550800

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