Reprocessed Oscillating Sagittal Saw Blade, 31 x 9mm

GUDID B390KM332251

SURETEK MEDICAL

Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered Surgical power tool system handpiece, sawing, line-powered
Primary Device IDB390KM332251
NIH Device Record Key0fc94ae2-5e89-4c17-b18d-30022f63a734
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Oscillating Sagittal Saw Blade, 31 x 9mm
Version Model NumberKM33-225
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
HIBCCB390KM332251 [Primary]

FDA Product Code

GFABlade, Saw, General & Plastic Surgery, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-28
Device Publish Date2021-05-20

Devices Manufactured by SURETEK MEDICAL

B39044471 - Reprocessed ECTRA II, Probe Knife2024-02-29
B390AR659208401 - Reprocessed PassPort Button Cannula, 8mm x 4cm2024-02-29
B390138505101 - Reprocessed MicroNeedle 3cm2024-02-28
B3905100371131 - Reprocessed Small Tear Cross Cut Rasp, 11mm x 5mm2024-02-20
B3905100371141 - Reprocessed Large Tear Cross Cut Rasp, 14.0mm x 7.0mm2024-02-20
B390810101 - Reprocessed Carpal Tunnel Release Blade2024-02-02
B3901912050T1 - Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing2024-01-04
B390E16511 - Reprocessed Straight Micro-Needle Electrode, 3cm2023-12-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.