GUDID 00613994776242

BUR TN40RCD TRANSNASAL 4MM RND CRS DIAMD

MEDTRONIC XOMED, INC.

Orthopaedic bur, reusable Orthopaedic bur, reusable
Primary Device ID00613994776242
NIH Device Record Keyce1b725b-a6aa-44ca-9d96-a4537739c96b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTN40RCD
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Dimensions

Angle15 degree
Angle15 degree
Angle15 degree
Angle15 degree
Angle15 degree
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994776242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-22

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