Reprocessed 3.5mm Cannulated Drill Bit, 160mm

GUDID B390310681

SURETEK MEDICAL

Fluted surgical drill bit, single-use
Primary Device IDB390310681
NIH Device Record Key5f16fdc4-9733-489a-b536-2ef5c594cd99
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed 3.5mm Cannulated Drill Bit, 160mm
Version Model Number310.68
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
HIBCCB390310681 [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 Date2021-11-18
Device Publish Date2021-11-10

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