N/A

GUDID 00763000039905

PACKING 1428005 6PK LONG STRIPS POLYEST

MEDTRONIC XOMED, INC.

Polyethylene craniofacial tissue reconstructive material
Primary Device ID00763000039905
NIH Device Record Key1ea85a17-a912-4886-88f6-c4ffcf6e2024
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number1428005
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count6
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter
Width50.8 Millimeter
Length6.4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000039905 [Unit of Use]
GS120763000039909 [Primary]

FDA Product Code

NOKMATERIAL, EXTERNAL AESTHETIC RESTORATION, NO ADHESIVE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-01
Device Publish Date2021-02-21

On-Brand Devices [N/A]

20613994839637INSTRUMENT WIPE 2218525 25PK 9CM X 9CM
00613994513953PROBE 945CNP2002 100MM CONCENTRIC
00613994370075BUR 31113065 3MM CRS DIAMOND MED LENGTH
00613994370068BUR 31112565 2.5MM CRS DIAMD MED LENGTH
00613994370051BUR 31112065 2MM CRS DIAMOND MED LENGTH
00613994370020BUR 31133065 3MM FINE DIAMOND MED LENGTH
00613994370013BUR 31132565 2.5MM FINE DIAMD MED LENGTH
00613994370006BUR 31132065 2MM FINE DIAMD MED LENGTH
00613994369994BUR 31131565 1.5MM FINE DIAMD MED LENGTH
00613994369987BUR 31131066 1MM FINE DIAMD MED LENGTH
00613994369970BUR 31130566 .5MM FINE DIAMD MED LENGTH
00613994369963BUR 31313065UE ULTRA 3MM STEEL MED LGTH
00613994369956BUR 31312565UE ULTRA 2.5MM STL MED LGTH
00613994369949BUR 31312065 2MM STEEL MED LENGTH
00613994369932BUR 31311565 1.5MM STEEL MED LENGTH
00613994369925BUR 31311066 1MM STEEL MED LENGTH
00613994353184BUR 31133565 3.5MM FINE DIAMD MED LENGTH
00613994353122BUR 31113565 3.5MM CRS DIAMD MED LENGTH
00613994353023BUR 31313565UE ULTRA 3.5MM STEEL MED L
00613994353016BUR 31311075 1MM STEEL X-LONG
00613994353009BUR 31311575 1.5MM STEEL X-LONG
00613994352996BUR 31312075 2MM STEEL X-LONG
00613994352989BUR 31312575 2.5MM STEEL X-LONG
00613994352972BUR 31313075UE ULTRA 3MM STEEL X-LONG
00613994352965BUR 31313575UE ULTRA 3.5MM STEEL X-LONG
00613994352958BUR 31314075UE ULTRA 4MM STEEL X-LONG
20613994233329BLADE 1884080HR 5PK TRICUT M4 13CM 4MM
00613994233233BUR 1885078HSE 13CM X 5MM 70DEG DIAMOND
00613994233219BUR 1883277HSE 15CM X 3.2MM 40DG DIAMOND
00613994233196BUR 1885076HSE 15CM X 5MM 15DEG DIAMOND
00613994233189BUR 1884075HSE 15CM X 4MM 15DEG CUTTING
00613994233165BUR 1883274HSE 15CM X 3.2MM 15DG DIAMOND
00613994221476BUR 31236058 6MM SST PEAR MED LENGTH
00613994221469BUR 31255558 5.5MM SST OVAL MED LENGTH
00613994221421BUR 31134065 4MM FINE DIAMOND MED LENGTH
00613994221414BUR 31135059 5MM FINE DIAMOND MED LENGTH
00613994221407BUR 31136058 6MM FINE DIAMOND MED LENGTH
00613994221391BUR 31114065 4MM CRSE DIAMOND MED LENGTH
00613994221377BUR 31115059 5MM CRSE DIAMOND MED LENGTH
00613994221360BUR 31116058 6MM CRSE DIAMOND MED LENGTH
00613994102232BUR 31314065UE ULTRA 4MM MED LENGTH
20613994102229BUR 31314065U ULTRA 5PK 4MM MED LENGTH
00613994102218BUR 31315059UE ULTRA 5MM MED LENGTH
20613994102205BUR 31315059U ULTRA 5PK 5MM MED LENGTH
00613994102188BUR 31316058UE ULTRA 6MM MED LENGTH
20613994102175BUR 31316058U ULTRA 5PK 6MM MED LENGTH
00613994102164BUR 31317057UE ULTRA 7MM MED LENGTH
20613994102151BUR 31317057U ULTRA 5PK 7MM MED LENGTH
00613994097170BUR 31135051 5MM FINE DIAMOND STD LENGTH
00643169938847ELECTRODE 8227703 PRD NDL 22MM 8CH ROHS
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.