Austin / Polycel®

GUDID 00763000035396

PROSTHESIS 1156305 AUSTIN TOTAL 3MM HD

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total
Primary Device ID00763000035396
NIH Device Record Keyb05b7f29-81b8-4ef5-b27e-59eb458a270e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAustin / Polycel®
Version Model Number1156305
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
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 Dimensions

Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length8 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000035396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBMPOROUS POLYETHYLENE OSSICULAR REPLACEMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-15
Device Publish Date2021-11-07

On-Brand Devices [Austin / Polycel®]

00763000035440PROSTHESIS 1156361 AUSTIN OFFSET PARTIAL
00763000035396PROSTHESIS 1156305 AUSTIN TOTAL 3MM HD

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