Reprocessed 2.9mm Full Radius Resector

GUDID B390C9941A1

SURETEK MEDICAL

Arthroscopic shaver system blade, reprocessed
Primary Device IDB390C9941A1
NIH Device Record Keye201ecbb-1237-4230-b62c-d4c1c8c2533e
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed 2.9mm Full Radius Resector
Version Model NumberC9941A
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
HIBCCB390C9941A1 [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 Date2021-04-15
Device Publish Date2021-04-07

On-Brand Devices [Reprocessed 2.9mm Full Radius Resector]

B390C9941A1C9941A
B390C9944A1C9944A

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