FDA.report

KOMET Surgical Bur

Primary DI
24053613271237
Brand
KOMET Surgical Bur
Company
Gebr. Brasseler GmbH & Co. KG
Model
NC0107.014..K2
Catalog number
NC0107.014.
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
false
Single use
false

Related Records

Product Codes

CodeName
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24053613271237PackageGS15In Commercial Distribution
14053613271230PrimaryGS10

GMDN Terms

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
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 DIBrandModelCatalogPublished
24053613265496Steinmann PinSP-80005-00-00SP-80005-00-002026-03-20
24053613296209Bur, tapered, round shank08227100082271002026-03-20
24053613295929Bur, Round, round shank08226780082267802026-03-11
24053613295936Bur, Round, round shank08226790082267902026-03-11
24053613296131Bur, Round, round shank08227000082270002026-03-11
24053613296193Bur, tapered, round shank08227090082270902026-03-11
24053613296803Bur, Round, round shank08227750082277502026-03-11
24053613297121Bur, cylindrical, round shank08228070082280702026-03-11
24053613297190Bur, Egg / egg shaped, round shank08228140082281402026-03-11
24053613297206Bur, Egg / egg shaped, round shank08228150082281502026-03-11
24053613297220Bur, Round, round shank08228170082281702026-03-11
04053613298315Guide Pin Smooth800-05-215800-05-2152026-03-11
84053613294535Guide Pin Smooth800-05-215800-05-2152026-01-30
24053613295721Shannon Recta X-LargaG01 S5330G01 S53302026-01-23
24053613284978Saw Blade5109-098-0435109-098-0432022-12-08
E226048483R18KOMET Root Canal Files17331.654.012.R117331.654.0122026-01-13
14053613294581Tech Ancillary Pack150-00-002150-00-0022026-01-08
24053613294557Guide Drill Pin800-02-508800-02-5082026-01-06
14053613294574Tech Knee Pack150-00-001150-00-0012026-01-06
E226007158R18KOMET Root Canal Files17321.654.006.R117321.654.0062025-12-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
24053613296209Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-20
07613327687637N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687644N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687651N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687668N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687675N/ASTRYKER CORPORATIONGFF2026-03-19
24053613295929Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613295936Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296131Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296193Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296803Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297121Bur, cylindrical, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297190Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297206Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297220Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
10888867516950Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517926Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517933Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517940Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517957Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517964Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544052Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544069Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544076Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544083Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544090Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544106Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544120Arthrex®ARTHREX, INC.GFF2026-03-03
04027497285884GT PODO 0.276 in (7 mm) round Shank 3/32"LUKAS-ERZETT GmbH & Co. KGGFF2026-02-11
04027497285822GT PODO 0.394 in (10 mm) round Shank 3/32"LUKAS-ERZETT GmbH & Co. KGGFF2026-02-10