Bojrab

GUDID 00681490023764

PROSTHESIS 0506 BOJRAB UNIVERSAL 7MM

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total Ossicular prosthesis, total
Primary Device ID00681490023764
NIH Device Record Key6089ac25-d9f8-4723-98cc-24a562856b5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBojrab
Version Model Number0506
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490023764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETAREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-15

On-Brand Devices [Bojrab]

00681490023788PROSTHESIS 0507 BOJRAB UNIV 9.0
00681490023764PROSTHESIS 0506 BOJRAB UNIVERSAL 7MM
00681490017572PROSTHESIS 0308 BOJRAB UNIV H/A OFFSET
00681490017565PROSTHESIS 0306 BOJRAB UNIV HA 7MM
00721902817427PROSTHESIS 0385 BOJRAB UNIV POLYCEL
00763000036508PROSTHESIS 0385 BOJRAB UNIV POLYCEL
00763000034375PROSTHESIS 0507 BOJRAB UNIV 9.0
00763000034368PROSTHESIS 0506 BOJRAB UNIVERSAL 7MM
00763000034221PROSTHESIS 0308 BOJRAB UNIV H/A OFFSET
00763000034214PROSTHESIS 0306 BOJRAB UNIV HA 7MM

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