DEVICE: DORO® Swivel Adaptor Radiolucent (04250435502044)

Device Identifier (DI) Information

DORO® Swivel Adaptor Radiolucent
3033-00
In Commercial Distribution

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
04250435502044
GS1

1
313517922 *Terms of Use
DORO® Swivel Adaptor Radiolucent
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
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No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HBL Holder, Head, Neurosurgical (Skull Clamp)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K063494 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7717fdbf-e62c-411a-ac62-99c11756400b
July 08, 2021
5
December 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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