Bio-Flek

GUDID 00763000299101

HEAD SUPPORT 1358225 BIOFLEK SURGICAL

MEDTRONIC XOMED, INC.

ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest
Primary Device ID00763000299101
NIH Device Record Key755a61ed-22dc-456b-ada5-c4d195bd4f41
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-Flek
Version Model Number1358225
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000299101 [Primary]

FDA Product Code

EPWSupport, head, surgical, ENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-25

On-Brand Devices [Bio-Flek]

00763000299118HEAD SUPPORT 1358227 BIOFLEK RISER
00763000299101HEAD SUPPORT 1358225 BIOFLEK SURGICAL

Trademark Results [Bio-Flek]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIO-FLEK
BIO-FLEK
73626253 1467164 Live/Registered
TREACE MEDICAL, INC.
1986-10-21

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