DEVICE: DORO LUCENT® Parallelogram Adaptor (04250435516287)

Device Identifier (DI) Information

DORO LUCENT® Parallelogram Adaptor
4003.211
In Commercial Distribution

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
04250435516287
GS1

1
313517922 *Terms of Use
DORO LUCENT® Parallelogram Adaptor TRUMPF for SIEMENS Aera/Skyra MRI Systems
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Device Characteristics

MR Conditional
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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 to allow variable head positioning; it is not intended for applying traction forces to the cervical spine. This is a reusable device.
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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

[?]
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

6984adc1-4cf9-4197-a4ca-00247d2ea407
July 06, 2018
3
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)

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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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