DEVICE: Ascenda (00613994555595)
Device Identifier (DI) Information
Ascenda
8780
Not in Commercial Distribution
MEDTRONIC, INC.
8780
Not in Commercial Distribution
MEDTRONIC, INC.
CATH 8780 ASCENDA INTRATHECAL SHORT EMAN
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
61797 | Lumbar cerebrospinal fluid drainage catheterization kit |
A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P860004 | 125 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between -34 and 57 Degrees Celsius |
Handling Environment Temperature: between -30 and 135 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Length: 86.0 Centimeter |
Device Record Status
2a63dba3-4c60-4dd5-8423-6bf833f423e4
December 23, 2024
5
April 27, 2016
December 23, 2024
5
April 27, 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
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com