Reprocessed 4.0mm CoolCut Dissector Blade

GUDID B390AR8400DS1

4.0mm CoolCut Dissector Blade

SURETEK MEDICAL

Arthroscopic shaver system blade, reprocessed
Primary Device IDB390AR8400DS1
NIH Device Record Keye1c35523-5efb-4268-bd7f-21337b431ba5
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed 4.0mm CoolCut Dissector Blade
Version Model NumberAR-8400DS
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
HIBCCB390AR8400DS1 [Primary]

FDA Product Code

NBHAccessories, Arthroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-07-04
Device Publish Date2020-11-18

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