GUDID 00613994418678

ATT BM100 LEGEND PNEUM BONE MILL BASE

MEDTRONIC POWERED SURGICAL SOLUTIONS

Burring power tool attachment
Primary Device ID00613994418678
NIH Device Record Keyf8153784-64ba-4caa-96d2-8bad209d6202
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBM100
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994418678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBBMOTOR, DRILL, PNEUMATIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994418678]

Moist Heat or Steam Sterilization


[00613994418678]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-26

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00763000753382 - ENT MR82024-06-17 UR 1847B20SCT ENTMR8 CUT 2MM STD
00763000753412 - ENT MR82024-06-17 UR 1847B20SDM ENTMR8 DMD MED 2MM STD
00763000714550 - MR8 Tools2024-05-06 TOOL MR8-14TD3030 MR8 TWIST DRL 3MMX30MM
00763000732943 - MR82024-01-26 TOOL MR8-ND13BA30D MR8 13CM ND B D 3MM
00763000732967 - MR82024-01-26 TOOL MR8-SD12BA30D MR8 12CM SD B D 3MM

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