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
14053613286357Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.425S05.005.425S2026-09-25
14053613286388Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.464S05.005.464S2026-09-25
14053613286401Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.434S05.005.434S2026-09-25
14053613286463Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.466S05.005.466S2026-09-25
14053613286500Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.435S05.005.435S2026-09-25
14053613286623Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.105S05.005.105S2026-09-25
14053613286807Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.170S05.519.170S2026-09-25
14053613286838Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.230S05.519.230S2026-09-25
14053613286845Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.104S05.519.104S2026-09-25
14053613286852Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.103S05.519.103S2026-09-25
14053613286869Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.250S05.519.250S2026-09-25
14053613286876Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.105S05.519.105S2026-09-25
14053613286883Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.150S05.519.150S2026-09-25
14053613286890Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.100S05.519.100S2026-09-25
14053613286913Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.301S05.519.301S2026-09-25
14053613286920Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.302S05.519.302S2026-09-25
14053613286937Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.303S05.519.303S2026-09-25
14053613295649Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.906S05.005.906S2026-09-25
14053613295694Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.914S05.005.914S2026-09-25
E226004255A21KOMET Dental Diamond Instruments813.314.010.A2813.314.0102023-01-31

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