DEVICE: NA (00643169466197)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
61523 | Lumboperitoneal shunt |
An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity where it can be absorbed into the body, as a treatment for raised CSF pressure (e.g., caused by hydrocephalus). It consists of fully-implantable interconnected components: a spinal catheter implanted into subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a puncturable port/reservoir for sampling/infusion; a peritoneal catheter implanted into the peritoneal cavity; some types incorporate a subcutaneous anchor for component connection/positioning. Disposable devices associated with implantation may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JXG | Shunt, central nervous system and components |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K831396 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 87.0 Centimeter |
Lumen/Inner Diameter: 0.7 Millimeter |
Device Record Status
4a179c1c-b715-48f7-bfcb-300d335a3af1
April 07, 2021
4
July 10, 2015
April 07, 2021
4
July 10, 2015
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
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com