ENT MR8

GUDID 00763000356330

BUR ENTMR8 1847B80SDM DMD MED 8MM STD

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use
Primary Device ID00763000356330
NIH Device Record Key75c6c112-bd02-4b92-aa3f-a38d8622c63e
Commercial Distribution StatusIn Commercial Distribution
Brand NameENT MR8
Version Model Number1847B80SDM
Company DUNS098308849
Company NameMEDTRONIC POWERED SURGICAL SOLUTIONS
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]
GS100763000356330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [ENT MR8]

00763000356712BUR ENTMR8 1847B40SDX DMD XCRS 4MM STD
00763000356705BUR ENTMR8 1847B50SDX DMD XCRS 5MM STD
00763000356699BUR ENTMR8 1847B60SDX DMD XCRS 6MM STD
00763000356682BUR ENTMR8 1847B10LDC DMD CRS 1MM LNG
00763000356675BUR ENTMR8 1847B15LDC DMD CRS 1.5MM LNG
00763000356668BUR ENTMR8 1847B20LDC DMD CRS 2MM LNG
00763000356651BUR ENTMR8 1847B30LDC DMD CRS 3MM LNG
00763000356644BUR ENTMR8 1847B35LDC DMD CRS 3.5MM LNG
00763000356637BUR ENTMR8 1847B40LDC DMD CRS 4MM LNG
00763000356620BUR ENTMR8 1847B10SDC DMD CRS 1MM STD
00763000356613BUR ENTMR8 1847B15SDC DMD CRS 1.5MM STD
00763000356606BUR ENTMR8 1847B20SDC DMD CRS 2MM STD
00763000356590BUR ENTMR8 1847B25SDC DMD CRS 2.5MM STD
00763000356576BUR ENTMR8 1847B40SDC DMD CRS 4MM STD
00763000356569BUR ENTMR8 1847B50SDC DMD CRS 5MM STD
00763000355975BUR ENTMR8 1847B35SCT CUT 3.5MM STD
00763000355968BUR ENTMR8 1847B40SCT CUT 4MM STD
00763000356552BUR ENTMR8 1847B60SDC DMD CRS 6MM STD
00763000356545BUR ENTMR8 1847B70SDC DMD CRS 7MM STD
00763000356538BUR ENTMR8 1847B06LDM DMD MED 0.6MM LNG
00763000356521BUR ENTMR8 1847B08LDM DMD MED 0.8MM LNG
00763000356514BUR ENTMR8 1847B10LDM DMD MED 1MM LNG
00763000356507BUR ENTMR8 1847B12LDM DMD MED 1.2MM LNG
00763000356491BUR ENTMR8 1847B15LDM DMD MED 1.5MM LNG
00763000356484BUR ENTMR8 1847B20LDM DMD MED 2MM LNG
00763000356477BUR ENTMR8 1847B25LDM DMD MED 2.5MM LNG
00763000356460BUR ENTMR8 1847B30LDM DMD MED 3MM LNG
00763000356453BUR ENTMR8 1847B35LDM DMD MED 3.5MM LNG
00763000356446BUR ENTMR8 1847B40LDM DMD MED 4MM LNG
00763000356439BUR ENTMR8 1847B10SDM DMD MED 1MM STD
00763000356422BUR ENTMR8 1847B15SDM DMD MED 1.5MM STD
00763000356415BUR ENTMR8 1847B20SDM DMD MED 2MM STD
00763000356408BUR ENTMR8 1847B25SDM DMD MED 2.5MM STD
00763000356392BUR ENTMR8 1847B30SDM DMD MED 3MM STD
00763000356385BUR ENTMR8 1847B35SDM DMD MED 3.5MM STD
00763000356378BUR ENTMR8 1847B40SDM DMD MED 4MM STD
00763000356323BUR ENTMR8 1847B10LDF DMD FINE 1MM LNG
00763000356316BUR ENTMR8 1847B15LDF DMD FINE 1.5MM LNG
00763000356309BUR ENTMR8 1847B20LDF DMD FINE 2MM LNG
00763000356293BUR ENTMR8 1847B25LDF DMD FINE 2.5MM LNG
00763000356286BUR ENTMR8 1847B30LDF DMD FINE 3MM LNG
00763000356279BUR ENTMR8 1847B40LDF DMD FINE 4MM LNG
00763000356262BUR ENTMR8 1847B50LDF DMD FINE 5MM LNG
00763000356255BUR ENTMR8 1847B10SDF DMD FINE 1MM STD
00763000356248BUR ENTMR8 1847B15SDF DMD FINE 1.5MM STD
00763000356231BUR ENTMR8 1847B20SDF DMD FINE 2MM STD
00763000356224BUR ENTMR8 1847B25SDF DMD FINE 2.5MM STD
00763000356217BUR ENTMR8 1847B30SDF DMD FINE 3MM STD
00763000356200BUR ENTMR8 1847B40SDF DMD FINE 4MM STD
00763000356194BUR ENTMR8 1847B50SDF DMD FINE 5MM STD

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.