DEVICE: Medicon (04046826108434)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
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Device Identifier (DI) Information
Medicon
63.60.20
In Commercial Distribution
63.60.20
Medicon eG. Chirurgiemechaniker-Genossenschaft
63.60.20
In Commercial Distribution
63.60.20
Medicon eG. Chirurgiemechaniker-Genossenschaft
cut burr bud 70mm 5.0mm
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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
db201072-e69e-4d1a-85b8-9848cf5bf151
April 18, 2024
1
April 10, 2024
April 18, 2024
1
April 10, 2024
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+490746220090
sales@medicon.de
sales@medicon.de