FDA.reportPublic FDA data

Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II

Primary DI
14053613286326
Brand
Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II
Company
Gebr. Brasseler GmbH & Co. KG
Model
05.005.423S
Catalog number
05.005.423S
Published
2026-10-05
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
14053613286326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1405361328632614053613286326

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, sagittal, single-useA 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 sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device.

Regulatory Flags#

DUNS number
317409001
Device count
1
DM exempt
false
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
14053613001738KOMET Surgical BurNC0310.010..M0NC0310.010.2023-01-31
E226000085G11KOMET Dental Tungsten Carbide BursH1.314.006.G1H1.314.0062023-01-19
E226000087AL1KOMET Dental Tungsten Carbide BursH1.314.008.ALH1.314.0082023-01-19
E226000091G11KOMET Dental Tungsten Carbide BursH1.314.014.G1H1.314.0142023-01-24
E226000092A11KOMET Dental Tungsten Carbide BursH1.314.016.A1H1.314.0162023-01-24
E226000104AL1KOMET Surgical BurH1.316.010.ALH1.316.0102023-01-24
E226000104G11KOMET Surgical BurH1.316.010.G1H1.316.0102023-01-24
E226000106AL1KOMET Surgical BurH1.316.014.ALH1.316.0142023-01-27
E226000108G11KOMET Surgical BurH1.316.018.G1H1.316.0182023-01-31
E226000109G11KOMET Surgical BurH1.316.023.G1H1.316.0232023-01-31
E226000150AU1KOMET Dental Tungsten Carbide BursH2.313.008.AUH2.313.0082023-01-31
14053613286302Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.422S05.005.422S2026-10-05
14053613286418Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.465S05.005.465S2026-10-05
14053613286432Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.441S05.005.441S2026-10-05
14053613286661Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.203S05.005.203S2026-10-05
14053613286708Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.303S05.005.303S2026-10-05
14053613286814Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.200S05.519.200S2026-10-05
14053613287026Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.002S05.005.002S2026-10-05
E226000077AU1KOMET Dental Tungsten Carbide BursH1.313.010.AUH1.313.0102023-01-19
E226000081AU1KOMET Dental Tungsten Carbide BursH1.313.018.AUH1.313.0182023-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613286302Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286418Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286432Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286661Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286708Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286814Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613287026Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286364Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286395Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286425Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286449Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286456Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286470Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286487Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286494Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286722Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286777Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286784Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286791Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
14053613286944Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-01
G14154661010Carnegie Surgical LLCCarnegie Surgical LLCGFA2026-09-30
G14154661030Carnegie Surgical LLCCarnegie Surgical LLCGFA2026-09-30
14053613286630Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-28
14053613286357Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286388Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286401Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286463Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286500Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286623Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286807Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25