Reprocessed Small Bone Osc Sagittal Blade, 18 x 5.5x 0.56mm

GUDID B390KM334121

SURETEK MEDICAL

Surgical power tool system handpiece, sawing, line-powered
Primary Device IDB390KM334121
NIH Device Record Keyc8f273a5-4258-447f-952d-4df77b5d3a49
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Small Bone Osc Sagittal Blade, 18 x 5.5x 0.56mm
Version Model NumberKM33-412
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
HIBCCB390KM334121 [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

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