FDA.reportPublic FDA data

Reprocessed Micro Oscillating Saw Blade, 9 x 10 x 0.38mm

Primary DI
B390229635291
Brand
Reprocessed Micro Oscillating Saw Blade, 9 x 10 x 0.38mm
Company
SURETEK MEDICAL
Model
2296-3-529
Published
2021-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B390229635291PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system handpiece, sawing, line-poweredA hand-held, line-powered device (which may in addition include a rechargeable battery) that consists of a motorized saw handpiece intended to provide sagittal, oscillating, or reciprocating movement for attachable serrated blades designed to cut through hard/tough tissue during surgery. The device may be of the micro or macro design. It is powered from a control unit that supplies mains, stepped-down, low-voltage electricity (e.g., 24 volt) directly via an electrical connecting cable. It is typically operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785616934
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B390197230FLA1Reprocessed 4mm EndoScrub Sheath, 45 deg, K Storz197230FLA2026-04-30
B39019120501Reprocessed 4mm EndoScrub Sheath, 0 deg19-120502024-06-19
B390197230BVA1Reprocessed 4mm EndoScrub Sheath, 30 deg197230BVA2022-12-26
B3901912050T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing19-12050T2023-12-27
B39019120271Reprocessed 2.7mm EndoScrub Sheath, 30 deg19-120272021-06-16
B3901912101Reprocessed 4mm EndoScrub Sheath, 30 deg1912102021-06-16
B3901912131Reprocessed 4mm EndoScrub Sheath, 45 deg1912132021-06-16
B3901912201Reprocessed 4mm EndoScrub Sheath, 70 deg1912202021-06-16
B3901912000T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing19-12000T2021-06-15
B3901912001Reprocessed 4mm EndoScrub Sheath, 0 deg1912002021-06-15
B390191200T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing191200T2021-06-15
B39019120101Reprocessed 4mm EndoScrub Sheath, 30 deg19-120102021-06-15
B39019120131Reprocessed 4mm EndoScrub Sheath, 45 deg, K Storz19-120132021-06-15
B39019120201Reprocessed 4mm EndoScrub Sheath, 70 deg19-120202021-06-15
B3901912000Reprocessed Endoscrub Sheath, 4mm, 0 deg19-120002021-06-14
B39016005391Reprocessed Shaver Blade Straight 3.5mm Double Serrated16005392025-12-09
B39016005741Reprocessed Shaver Blade Curved, 60 Deg, Double Serrated16005742025-12-09
B3901884002HRT1Reprocessed 4.0mm Serrated Blade, Rotatable, with Tubing18-84002HRT2025-12-09
B39062901120331Reprocessed 3mm Straight Shaver Blade6290-112-0332025-12-09
B3906290112040121Reprocessed 4mm Angled 12 Degree Shaver Blade6290-112-040-122025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227421Saw BladeTreace Medical Concepts, Inc.GFA2026-08-25
00810111227445Saw BladeTreace Medical Concepts, Inc.GFA2026-08-25
37630055512506Long Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2026-08-25
37630055512537Long Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2026-08-25
37630055512568Long Bullnose Blade 32x0.6mmBien-Air Surgery SAGFA2026-08-25
47630055512503Long Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2026-08-25
47630055512534Long Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2026-08-25
47630055512565Long Bullnose Blade 32x0.6mmBien-Air Surgery SAGFA2026-08-25
27630055512509Long Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2026-08-25
27630055512530Long Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2026-08-25
27630055512561Long Bullnose Blade 32x0.6mmBien-Air Surgery SAGFA2026-08-25
B504OM22963414S70StrykerProvisionGFA2026-07-20
B504OM41251470900StrykerProvisionGFA2026-07-20
B504OM50711850Conmed LinvatecProvisionGFA2026-07-20
B504OM51003372330StrykerProvisionGFA2026-07-20
47630055517706Short Oscillating Blade 6x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055517737Short Oscillating Blade 9x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055517768Long Oscillating Blade 6x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055517799Long Oscillating Blade 9x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055519212Short Oscillating Blade 5x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055519243Long Oscillating Blade 5x0.4mmBien-Air Surgery SAGFA2026-04-21
07613327576566PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576672PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576696PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576719PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576733PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576740PELLOSTRYKER CORPORATIONGFA2023-09-13
17630055512236Short Bullnose Blade 22x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512243Short Bullnose Blade 22x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512250Short Bullnose Blade 22x0.4mmBien-Air Surgery SAGFA2023-02-17