DEVICE: QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit (B238H000036320)
Device Identifier (DI) Information
QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit
NA
In Commercial Distribution
H0000-3632
HEMEDEX, INC
NA
In Commercial Distribution
H0000-3632
HEMEDEX, INC
Intracranial Dual Lumen Bolt Kit
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
61401 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HBG | Drills, Burrs, Trephines & Accessories (Manual) |
GWM | Device, Monitoring, Intracranial Pressure |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141869 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1dac0e98-77f8-4aa2-bad0-448e5a52b3b5
July 06, 2018
3
September 21, 2016
July 06, 2018
3
September 21, 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 |
---|---|
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