DEVICE: Custom Healthcare Systems Inc. (00811870031854)
Device Identifier (DI) Information
Custom Healthcare Systems Inc.
B9-15620B
In Commercial Distribution
Manus Medical, LLC
B9-15620B
In Commercial Distribution
Manus Medical, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
35199 | Myelography kit |
A collection of devices designed for injecting contrast medium into the subarachnoid (intrathecal) space (usually of the lumbar spine) for the purposes of visualizing the spinal canal by radiographic study. It is also referred to as myelogram tray and typically includes a needle, syringe, tubing, contrast medium, and other consumable items. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OGJ | Nerve Block Tray |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
acdfc7ad-d5b1-441e-a7f7-1b83799942fa
June 08, 2023
3
July 30, 2018
June 08, 2023
3
July 30, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20811870031858 | 20 | 00811870031854 | In Commercial Distribution | N/A |
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