2.7MM SYSTEM 99-9952

GUDID 00841036058579

CROSS-DRIVE EMERGENCY SCREW 3.2X12MM

BIOMET MICROFIXATION, INC

Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable
Primary Device ID00841036058579
NIH Device Record Key341e6c5b-3d89-441f-93fe-548e06594901
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.7MM SYSTEM
Version Model Number99-9952
Catalog Number99-9952
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM
Phone904-741-4400
EmailFXJAX-ORDERS@BIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036058579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPlate, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


[00841036058579]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-17

On-Brand Devices [2.7MM SYSTEM]

00841036152710SP-2843
00841036152697SP-2842
00841036065638CROSS-DRIVE EMERGENCY SCREW 3.2X16MM
00841036058579CROSS-DRIVE EMERGENCY SCREW 3.2X12MM
00841036058562CROSS-DRIVE EMERGENCY SCREW 3.2X10MM
00841036058555CROSS-DRIVE EMERGENCY SCREW 3.2X8MM
00841036018399DRILL 2.0X105MM 75MM STP J-NT
00841036018382DRILL 2.0X70MM 40MM STP J-NT
00888233019231SP-2843
00888233019217SP-2842

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