FDA.reportPublic FDA data

KOMET Surgical Saw Blade

Primary DI
24053613176549
Brand
KOMET Surgical Saw Blade
Company
Gebr. Brasseler GmbH & Co. KG
Model
KM37115. ST..M1
Catalog number
KM37115. ST.
Published
2023-02-01
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
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
24053613176549PackageGS11In Commercial Distribution
14053613176542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2405361317654924053613176549
1405361317654214053613176542

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, reciprocating, reusableA surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to be attached to a reciprocating power tool handpiece to scrape and smooth the surface of bone during a surgical procedure. It has grooves/teeth along all or part of the distal working end and is made of metal [e.g., stainless steel, titanium (Ti)]; it is not dedicated for use at a specific anatomy (e.g., sinus, ear). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317409001
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
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
14053613275160KOMET Surgical Saw BladeKM005.000..K2KM005.000.2023-02-01
14053613275658KOMET Surgical Saw BladePC5160.000..K2PC5160.000.2023-02-01

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