Sheehy HA/C Polycel® P.O.P.

GUDID 00763000034832

PROSTHESIS 1112362 SHEEHY POP H/A POLYCL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial
Primary Device ID00763000034832
NIH Device Record Key8dfc0728-90ab-420d-ab3e-f6e241e50f55
Commercial Distribution StatusIn Commercial Distribution
Brand NameSheehy HA/C Polycel® P.O.P.
Version Model Number1112362
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
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

Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.75 Millimeter
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000034832 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-20
Device Publish Date2024-05-12

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