DEVICE: QFlow 500 Titanium Bolt-Single Lumen (B238H000036010)

Device Identifier (DI) Information

QFlow 500 Titanium Bolt-Single Lumen
NA
In Commercial Distribution
H0000-3601
HEMEDEX, INC
B238H000036010
HIBCC

1
128045676 *Terms of Use
Intracranial Single Lumen Bolt
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Device Characteristics

MR Unsafe
No
No
Yes
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
Intracerebral catheter cranial-fixation kit A collection of sterile devices intended to be used to affix an intracerebral sensor/infusion/drainage catheter on the skull of a patient. It includes cranial screws and screwing tools; it does not include the intracerebral catheter, and does not include devices intended for long-term implantation (> 30 days). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GWM Device, Monitoring, Intracranial Pressure
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141869 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e46afc61-b516-41dd-8571-6027c7b0afad
July 06, 2018
3
September 21, 2016
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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
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Secondary DI

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

[?]
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

[?]
No Customer Contact currently defined
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