Reprocessed 4mm Round Fine Diamond Bur Long

GUDID B390311340681

SURETEK MEDICAL

Orthopaedic bur, reusable
Primary Device IDB390311340681
NIH Device Record Key6a9c6bfb-3358-4a8f-bf7f-26af6653fd14
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed 4mm Round Fine Diamond Bur Long
Version Model Number31134068
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
HIBCCB390311340681 [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 Date2025-07-31
Device Publish Date2025-07-23

Devices Manufactured by SURETEK MEDICAL

B39016005391 - Reprocessed Shaver Blade Straight 3.5mm Double Serrated2025-12-17
B39016005741 - Reprocessed Shaver Blade Curved, 60 Deg, Double Serrated2025-12-17
B3901884002HRT1 - Reprocessed 4.0mm Serrated Blade, Rotatable, with Tubing2025-12-17
B39062901120331 - Reprocessed 3mm Straight Shaver Blade2025-12-17
B3906290112040121 - Reprocessed 4mm Angled 12 Degree Shaver Blade2025-12-17
B3906290112040601 - Reprocessed 4mm Angled 60 Degree Shaver Blade2025-12-17
B3901161701 - Reprocessed Mako Blade Standard, 2mm2025-09-26
B3901161711 - Reprocessed Mako Blade Narrow, 2mm2025-09-26

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.