DEVICE: NA (00613994533579)
Device Identifier (DI) Information
NA
8516
Not in Commercial Distribution
MEDTRONIC, INC.
8516
Not in Commercial Distribution
MEDTRONIC, INC.
CATHETER KIT 8516 INTRASPINAL TRIAL 8ML
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? |
---|---|---|---|---|
47079 | Spinal infusion/drainage catheter |
A sterile flexible tube intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column for infusion of materials (typically anaesthetic or analgesic substances during surgery, labour, or delivery), and/or drainage of cerebrospinal fluid (CSF) and/or other fluids. Devices intended to assist catheter insertion (e.g., Tuohy needle, suture) may be included. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P860004 | 058 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
79d5e761-c24e-48ec-bea8-1a7eae6189bb
July 06, 2018
3
September 23, 2014
July 06, 2018
3
September 23, 2014
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