Reprocessed 6.0mm Slotted Reamer

GUDID B3901100103711

SURETEK MEDICAL

Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use
Primary Device IDB3901100103711
NIH Device Record Key74b33be1-bbd1-46c0-a206-4dbe0e08d1e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed 6.0mm Slotted Reamer
Version Model Number110010371
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
HIBCCB3901100103711 [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 Date2021-11-03
Device Publish Date2021-10-26

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