FDA.report

Bur, cylindrical, round shank

Primary DI
24053613297121
Company
Gebr. Brasseler GmbH & Co. KG
Model
08228070
Catalog number
08228070
Published
2026-03-11
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

Related Records

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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
24053613297121PackageGS11In Commercial Distribution
14053613297124PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
24053613297121PackageGS1114053613297124In Commercial Distribution
14053613297124PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
GFFBur, Surgical, General & Plastic Surgery1General, Plastic Surgery878.4820NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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Primary DIBrandCompanyProduct codePublished
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