DEVICE: Medicon (04046826108854)

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Device Record History
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Device Identifier (DI) Information
Medicon
63.68.12
In Commercial Distribution
63.68.12
Medicon eG. Chirurgiemechaniker-Genossenschaft
04046826108854
GS1

10
315492330 *Terms of Use
HM burr w dental shank 1.2mm p/10
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
46392 General/plastic surgery bur
A small rotary shaft of hard metal (e.g., steel) with fluting or cutting planes of various shapes on one end, designed to excavate soft tissue or cartilage during general and/or plastic surgery. It is usually power-driven by a rotary handpiece or other powered device. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HWE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
48c0fec5-9776-4d72-8bbf-9db3e713eb07
October 02, 2020
1
September 24, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 04046826317621 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+490746220090
sales@medicon.de
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