DEVICE: DORO® Skull Clamp System (04250435501870)
Device Identifier (DI) Information
DORO® Skull Clamp System
3022-00
In Commercial Distribution
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
3022-00
In Commercial Distribution
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
DORO® Universal Multi Purpose Skull Clamp System
consisting of:
3006-00
3006-10
3020-01
3020-02
3020-50
3020-55
3020-56
3020-61
3020-62
3020-63
3020-65
3020-68
3020-71
3020-001
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
35446 | Skull clamp |
A U-shaped surgical device intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints (either incorporated or separate) for positioning/stabilization; it is not intended for applying traction forces to the cervical spine. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HBL | Holder, Head, Neurosurgical (Skull Clamp) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K001808 | 000 |
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
0fd39123-7b92-4465-b53e-e31fa5619a7c
July 08, 2021
5
December 15, 2016
July 08, 2021
5
December 15, 2016
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 |
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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
[?]
No Customer Contact currently defined