Reprocessed Micro Cut Dual Blade, 18.5 x 9mm

GUDID B390540031031

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
Primary Device IDB390540031031
NIH Device Record Key5ba4acd9-ed06-4acb-989b-22760f01cc31
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Micro Cut Dual Blade, 18.5 x 9mm
Version Model Number5400-3-103
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
HIBCCB390540031031 [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 Date2021-05-04
Device Publish Date2021-04-26

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B3902296332121 - Reprocessed Micro Oscillating Sagittal Blade,18 x 5.5 mm2021-05-04
B3902296332251 - Reprocessed Long Medium Aggressive Blade, 31 x 9mm2021-05-04
B390229634121 - Reprocessed Medium Narrow Blade, 18 x 5.5mm2021-05-04
B390229635041 - Reprocessed Oscillating Saw Blade, 34.5 x 16.5mm2021-05-04
B390229635111 - Reprocessed Aggressive Medium Blade, 25 x 9 mm2021-05-04

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