Reprocessed 3.5 Stealth Full Radius Resector

GUDID B390SC92641

3.5mm Orange, Carbon Coated Gator Stealth Blade

SURETEK MEDICAL

Arthroscopic shaver system blade, reprocessed
Primary Device IDB390SC92641
NIH Device Record Key25e894ca-8464-4c5e-824b-cdbbe7caeb5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed 3.5 Stealth Full Radius Resector
Version Model NumberSC9264
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
HIBCCB390SC92641 [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 Date2019-08-21

On-Brand Devices [Reprocessed 3.5 Stealth Full Radius Resector]

B390SC926413.5mm Orange, Carbon Coated Gator Stealth Blade
B390SC924813.5mm Yellow, Carbon Coated Stealth Full Radius Resector

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