DEVICE: Disposable Radiolucent Skull Pins (3 Pcs) (04056481004767)

Device Identifier (DI) Information

Disposable Radiolucent Skull Pins (3 Pcs)
18910-01A
In Commercial Distribution
18910-01A
Brainlab AG
04056481004767
GS1

1
314482980 *Terms of Use
No description.
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Device Characteristics

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

GMDN

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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

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

FDA Premarket Submission Number [?] Supplement Number [?]
K122225 000
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Sterilization

Yes
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

1ce84d1c-f407-4436-82cc-94581b9bb80d
July 06, 2018
3
September 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
04056481132217 10 04056481004767 In Commercial Distribution
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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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+49899915680
contact@brainlab.com
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