FDA.reportPublic FDA data

KOMET Surgical Bur

Primary DI
14053613293133
Brand
KOMET Surgical Bur
Company
Gebr. Brasseler GmbH & Co. KG
Model
SC2834.502..K1
Catalog number
SC2834.502.
Published
2026-09-25
Public version status
New
Distribution status
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
GFFBur, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24053613293130PackageGS11In Commercial Distribution
14053613293133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2405361329313024053613293130
1405361329313314053613293133

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, reusableA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). 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
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
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
14053613286692Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.301S05.005.301S2026-10-19
14053613286975Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.072S05.005.072S2026-10-19
14053613286999Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.074S05.005.074S2026-10-19
14053613287002Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.075S05.005.075S2026-10-19
14053613287019Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.302S05.005.302S2026-10-19
14053613286562Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.501S05.005.501S2026-10-14
14053613286654Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.202S05.005.202S2026-10-14
14053613286906Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.190S05.519.190S2026-10-14
14053613298657KOMET GUIDE PIN/SCREWGP004.076.030.M4GP004.076.0302026-10-14
14053613286609Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.103S05.005.103S2026-10-13
14053613298275Reciprocating Saw Blade for ConMed®/Linvatec® Hall®AR-400-203AR-400-2032026-10-13
14053613298282Reciprocating Saw Blade for ConMed®/Linvatec® Hall®AR-400-204AR-400-2042026-10-13
14053613286579Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.101S05.005.101S2026-10-09
14053613286685Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.205S05.005.205S2026-10-09
14053613286739Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.001S05.005.001S2026-10-09
14053613286753Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.003S05.005.003S2026-10-09
14053613298336Pin DriverIN-20500IN-205002026-10-09
14053613286371Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.432S05.005.432S2026-10-07
14053613286586Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.106S05.005.106S2026-10-07
14053613286593Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.102S05.005.102S2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000108G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000109G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000106AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-27
E226000104AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
E226000104G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
10845854012581VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854012598VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854017791STERLINGConmed CorporationGFF2023-01-19
10845854029626STERLINGConmed CorporationGFF2023-01-19
10845854029671LIGHTNING, STERLINGConmed CorporationGFF2023-01-19
10845854040621ULTRATIGERConmed CorporationGFF2023-01-19
10080196377299MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10080196385577MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10884389198537MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10653160274797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160276982CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160281672CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160282402CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160290797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160321668CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01