FDA.reportPublic FDA data

Long Bullnose Blade 32x0.6mm

Primary DI
37630055512568
Brand
Long Bullnose Blade 32x0.6mm
Company
Bien-Air Surgery SA
Model
1502742
Catalog number
1502742-003
Published
2026-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
37630055512568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3763005551256837630055512568

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.

Regulatory Flags#

DUNS number
481597719
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17630055512236Short Bullnose Blade 22x0.4mm15027312023-02-17
17630055512243Short Bullnose Blade 22x0.4mm1502731-0031502731-0032023-02-17
17630055512250Short Bullnose Blade 22x0.4mm1502731-0101502731-0102023-02-17
17630055512267Short Bullnose Blade 27x0.4mm150273215027322023-02-17
17630055512274Short Bullnose Blade 27x0.4mm1502732-0031502732-0032023-02-17
17630055512281Short Bullnose Blade 27x0.4mm1502732-0101502732-0102023-02-17
17630055512298Short Bullnose Blade 32x0.4mm150273315027332023-02-17
17630055512304Short Bullnose Blade 32x0.4mm1502733-0031502733-0032023-02-17
17630055512311Short Bullnose Blade 32x0.4mm1502733-0101502733-0102023-02-17
17630055512328Short Bullnose Blade 22x0.6mm150273415027342023-02-17
17630055512335Short Bullnose Blade 22x0.6mm1502734-0031502734-0032023-02-17
17630055512342Short Bullnose Blade 22x0.6mm1502734-0101502734-0102023-02-17
17630055512359Short Bullnose Blade 27x0.6mm150273515027352023-02-17
17630055512366Short Bullnose Blade 27x0.6mm1502735-0031502735-0032023-02-17
17630055512373Short Bullnose Blade 27x0.6mm1502735-0101502735-0102023-02-17
17630055512380Short Bullnose Blade 32x0.6mm150273615027362023-02-17
17630055512403Short Bullnose Blade 32x0.6mm1502736-0101502736-0102023-02-17
17630055512410Long Bullnose Blade 22x0.4mm150273715027372023-02-17
17630055512427Long Bullnose Blade 22x0.4mm1502737-0031502737-0032023-02-17
17630055512434Long Bullnose Blade 22x0.4mm1502737-0101502737-0102023-02-17

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Primary DI, Brand, Company table
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