Reprocessed Arthrex 3.2mm Drill Bit, Cannulated

GUDID B390AR8750041

Arthrex Drill Bit, Cannulated, 3.2mm

SURETEK MEDICAL

Fluted surgical drill bit, single-use
Primary Device IDB390AR8750041
NIH Device Record Keybc212782-9f39-4852-af07-9d3c571548ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Arthrex 3.2mm Drill Bit, Cannulated
Version Model NumberAR-8750-04
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
HIBCCB390AR8750041 [Primary]

FDA Product Code

HTWBit, Drill

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-27
Device Publish Date2023-03-17

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