FDA.reportPublic FDA data

KOMET Surgical Saw Blade

Primary DI
14053613275160
Brand
KOMET Surgical Saw Blade
Company
Gebr. Brasseler GmbH & Co. KG
Model
KM005.000..K2
Catalog number
KM005.000.
Published
2023-02-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04053613275163Direct MarkingGS10
24053613275167PackageGS15Not in Commercial Distribution
14053613275160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053613275163040536132751634053613275163
2405361327516724053613275167
1405361327516014053613275160

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, sagittal, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613001998KOMET Surgical BurNC0612.004..M0NC0612.004.2023-01-31
14053613002322KOMET Surgical BurNS0101.012..M0NS0101.012.2023-01-31
14053613053232KOMET Surgical BurNS4101.009..M0NS4101.009.2023-02-01
14053613054222KOMET Surgical BurNS4001.027..M0NS4001.027.2023-02-01
14053613167298KOMET Surgical BurNS4002.027..M0NS4002.027.2023-02-01
14053613174227KOMET Surgical Saw BladeKMS2595.M62..M2KMS2595.M62.2023-02-01
14053613201060KOMET Surgical Saw BladeKM71125.C00..M0KM71125.C00.2023-09-29
14053613205525KOMET Surgical BurNC0186.016..M0NC0186.016.2023-02-01
14053613266892KOMET Surgical BurND1905.009..M0ND1905.009.2023-02-01
14053613266915KOMET Surgical BurND1903.004..M0ND1903.004.2023-01-31
14053613267578KOMET Surgical BurNS0101.012..K2NS0101.012.2023-01-31
14053613268599KOMET Surgical BurNS4101.009..K2NS4101.009.2023-02-01
14053613268612KOMET Surgical BurNS3601.027..K2NS3601.027.2023-02-01
14053613268650KOMET Surgical BurNS4002.027..K2NS4002.027.2023-02-01
14053613272435KOMET Surgical BurND1903.004..K2ND1903.004.2023-01-31
14053613273418KOMET Surgical BurND2001.004..K2ND2001.004.2023-01-31
14053613274491KOMET Surgical Saw BladeKM8672. AC..K2KM8672. AC.2023-02-01
14053613274514KOMET Surgical Saw BladeKM8673. AC..K2KM8673. AC.2023-02-01
14053613275658KOMET Surgical Saw BladePC5160.000..K2PC5160.000.2023-02-01
E226000453A11KOMET Dental Tungsten Carbide BursH33.314.009.A1H33.314.0092023-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613295632Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-10-20
14053613295656Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-10-20
14053613286692Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-19
14053613286975Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-19
14053613286999Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-19
14053613287002Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-19
14053613287019Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-19
14053613286562Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-14
14053613286654Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-14
14053613286906Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-14
14053613286609Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-13
14053613298275Reciprocating Saw Blade for ConMed®/Linvatec® Hall®Gebr. Brasseler GmbH & Co. KGGFA2026-10-13
14053613298282Reciprocating Saw Blade for ConMed®/Linvatec® Hall®Gebr. Brasseler GmbH & Co. KGGFA2026-10-13
14053613286579Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-09
14053613286685Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-09
14053613286739Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-09
14053613286753Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-09
14053613286371Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286586Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286593Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286616Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286647Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286678Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286746Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286760Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286951Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286968Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613295663Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613295670Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613295687Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-10-07