FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919985785
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
BML-S90016NS
Device description
BML-S90016NS
Published
2024-09-19
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863788000SAWBLADETava Surgical Instruments1986-10-14GFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919985785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919985785008879199857858879199857850887919985785

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, reciprocating, single-useA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535030853Brasseler USA5032379U05032379U02026-08-21
08404535030822Brasseler USA5032378U05032378U02026-07-13
00887919912125Brasseler USA5029292U05029292U02023-01-25
00887919752943Brasseler USA5025355U05025355U02026-07-27
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19
00887919711681Brasseler USA5024423U05024423U02026-06-19
00887919683902Brasseler USA5023604U05023604U02026-07-13
08404535030761Brasseler USA5032375U05032375U02026-07-13
08404535030792Brasseler USA5032376U05032376U02026-07-13
08404535018981Brasseler USA5031820U05031820U02026-06-26
08404535019018Brasseler USA5031821U05031821U02026-06-26
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27

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