GUDID 00613994776228

BUR TN30RCD TRANSNASAL 3MM RND CRS DIAMD

MEDTRONIC XOMED, INC.

Orthopaedic bur, reusable
Primary Device ID00613994776228
NIH Device Record Key0367f990-f5e7-4d5e-8d55-20e11ae39ab3
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTN30RCD
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

Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994776228 [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

Devices Manufactured by MEDTRONIC XOMED, INC.

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00763000578060 - N/A2024-09-24 SPLINT 1528137 25PK EXTERNAL NASAL LARGE

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