Reprocessed Shaver Blade Straight 3.0mm Double Serrated

GUDID B39016005381

SURETEK MEDICAL

ENT suction dissector
Primary Device IDB39016005381
NIH Device Record Key463aa0c2-77eb-4ea8-956c-182bdac842b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Shaver Blade Straight 3.0mm Double Serrated
Version Model Number1600538
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
HIBCCB39016005381 [Primary]

FDA Product Code

EQJBur, Ear, Nose And Throat

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-09
Device Publish Date2025-05-30

Devices Manufactured by SURETEK MEDICAL

B39016005401 - Reprocessed Shaver Blade Straight 4.0mm Double Serrated2025-06-30
B39062901120401 - Reprocessed 4mm Straight Shaver Blade2025-06-13
B39062902080251 - Reprocessed 2.5mm Straight Shaver Blade2025-06-13
B39072053121 - Reprocessed 3.5mm Incisor Blade2025-06-13
B39016005381 - Reprocessed Shaver Blade Straight 3.0mm Double Serrated2025-06-09
B39016005381 - Reprocessed Shaver Blade Straight 3.0mm Double Serrated2025-06-09
B39016010701 - Reprocessed Shaver Blade Straight 2.1mm Double Serrated2025-06-09
B3902833091 - Reprocessed 3.5mm Full Radius Blade Plus2025-06-02 3.5mm Full Radius Blade Plus, Yellow
B3902834091 - Reprocessed 4.0mm Full Radius Blade Plus2025-06-02 4.0mm Full Radius Blade Plus, 13cm, Yellow

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.