STERNALOCK 360 SYSTEM 74-1192

GUDID 00841036192136

BIOMET MICROFIXATION, INC

Nonimplantable needle guide, reusable
Primary Device ID00841036192136
NIH Device Record Key93fc73a0-dbb5-4ce8-9be5-3009f1fb1f3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERNALOCK 360 SYSTEM
Version Model Number74-1192
Catalog Number74-1192
Company DUNS046189866
Company NameBIOMET MICROFIXATION, INC
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

Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036192136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036192136]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2015-11-17

On-Brand Devices [STERNALOCK 360 SYSTEM]

0084103619213674-1192
0084103627527374-1193
0084103627526674-1192
0084103620248474-1195
0084103619214374-1193
0084103619066874-0004
0084103619023174-0016
0084103619022474-0014
0084103619021774-0012
0084103619020074-0010
0084103619002674-0002
0084103619001974-0003
0088823302660474-0004
0088823302659874-0003
0088823302658174-0002

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