Reprocessed Mako Blade Narrow, 2mm

GUDID B3901161711

SURETEK MEDICAL

Surgical saw blade, reciprocating, reprocessed
Primary Device IDB3901161711
NIH Device Record Keyd4f8efac-ce5b-4c21-8aab-23412a5e4556
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Mako Blade Narrow, 2mm
Version Model Number116171
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
HIBCCB3901161711 [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 Date2025-09-26
Device Publish Date2025-09-18

Devices Manufactured by SURETEK MEDICAL

B3901161701 - Reprocessed Mako Blade Standard, 2mm2025-09-26
B3901161711 - Reprocessed Mako Blade Narrow, 2mm2025-09-26
B3901161711 - Reprocessed Mako Blade Narrow, 2mm2025-09-26
B39021081821 - Reprocessed Sagittal Saw Blade, 18.6 x 1.24 x 84.4mm2025-09-15
B3903105201 - Reprocessed 1.8mm Drill Bit, Quick Coupling, 125mm2025-09-15
B390KM35251 - Reprocessed Small Bone Osc Sagittal Blade, Thin, 31 x 9 x 0.38mm2025-09-15
B390311340681 - Reprocessed 4mm Round Fine Diamond Bur Long2025-07-31
B390030001131 - Reprocessed 2.3mm Lindemann Reamer2025-07-28
B39016005401 - Reprocessed Shaver Blade Straight 4.0mm Double Serrated2025-06-30

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