Reprocessed 5.5mm Elite Acromionizer Bur

GUDID B390722007251

SURETEK MEDICAL

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Primary Device IDB390722007251
NIH Device Record Key918edd07-4160-4ebb-9d06-910f00402f56
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed 5.5mm Elite Acromionizer Bur
Version Model Number72200725
Company DUNS785616934
Company NameSURETEK MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB390722007251 [Primary]

FDA Product Code

NBHAccessories, Arthroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-17
Device Publish Date2021-11-09

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