DEVICE: KOMET Surgical Bur (E226048355A21)
Device Identifier (DI) Information
KOMET Surgical Bur
H379UF.310.014.A2
In Commercial Distribution
H379UF.310.014
Gebr. Brasseler GmbH & Co. KG
H379UF.310.014.A2
In Commercial Distribution
H379UF.310.014
Gebr. Brasseler GmbH & Co. KG
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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16668 | Carbide dental bur, reusable |
A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GFF | BUR, SURGICAL, GENERAL & PLASTIC SURGERY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7027ffc8-5b8d-4d2b-9896-4462e6d77964
February 09, 2023
1
February 01, 2023
February 09, 2023
1
February 01, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
E226048355A22 | 1 | E226048355A21 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
E226048355A28
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined