Oto-Flex

GUDID 00763000036058

BUR 3155645 OTO-FLEX 1.8MM DIAMD BRN/WH

MEDTRONIC XOMED, INC.

Orthopaedic bur, reusable
Primary Device ID00763000036058
NIH Device Record Key5f0902fe-fe53-4593-b335-6f6cc72e1f93
Commercial Distribution StatusIn Commercial Distribution
Brand NameOto-Flex
Version Model Number3155645
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Dimensions

Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter
Outer Diameter1.8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000036058 [Primary]

FDA Product Code

EQJBUR, EAR, NOSE AND THROAT

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000036058]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-22
Device Publish Date2021-03-12

On-Brand Devices [Oto-Flex]

00681490070430TREPHINE 3155628 OTO-FLEX 0.8MM BLACK
00681490070423SAW 3155627 OTO-FLEX CRURA .75MM BLACK
00681490070416DRILL 3155626 OTO-FLEX .6MM BLACK
00681490070409PERFORATOR 3155625 OTO-FLEX .5MM
00681490070393PERFORATOR 3155623 OTO-FLEX .35MM
00681490070386KNIFE 3155621 OTO-FLEX 2.3MM DIAMOND
00763000036089BUR 3155648 OTO-FLEX .8MM DIAMD YEL/WH
00763000036072BUR 3155647 OTO-FLEX .7MM DIAMD GRN/WH
00763000036065BUR 3155646 OTO-FLEX .6MM DIAMD BLUE/WH
00763000036058BUR 3155645 OTO-FLEX 1.8MM DIAMD BRN/WH
00763000036041BUR 3155643 OTO-FLEX 1.4MM DIAMD GRY/WH
00763000036034BUR 3155642 OTO-FLEX 2.3MM DIAMD RED/WH
00763000036027BUR 3155641 OTO-FLEX 1MM DIAMOND OR/WH
00763000036010BUR 3155639 OTO-FLEX 1.8MM CARB BROWN
00763000036003BUR 3155638 OTO-FLEX .8MM CARB YELLOW
00763000035990BUR 3155637 OTO-FLEX .7MM CARB GREEN
00763000035983BUR 3155636 OTO-FLEX .6MM CARB BLUE
00763000035976BUR 3155635 OTO-FLEX .5MM CARB VIOLET
00763000035952BUR 3155632 OTO-FLEX 2.3MM CARB RED
00763000035945BUR 3155631 OTO-FLEX 1.0MM CARB ORANGE
00763000035921SAW 3155627 OTO-FLEX CRURA .75MM BLACK
00763000035914DRILL 3155626 OTO-FLEX .6MM BLACK
00763000035907PERFORATOR 3155625 OTO-FLEX .5MM
00763000035891PERFORATOR 3155623 OTO-FLEX .35MM
00763000035884KNIFE 3155621 OTO-FLEX 2.3MM DIAMOND
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