Identity
- Trade Name
- ASCENDA® FDA UDI
- Generic Name
- Lumbar cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- CATHETER 8782 ASCENDA SPINAL REV KIT FDA UDI
- Model / Reference
- 8782 FDA UDI
- Description
- CATHETER 8782 ASCENDA SPINAL REV KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000051136 FDA UDI
- PMA Number
- P860004 FDA UDI
- FDA Product Code
- LKK FDA UDI
- GMDN Term
- Lumbar cerebrospinal fluid drainage catheterization kit FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 86.4 Centimeter FDA UDI
Category: Lumbar cerebrospinal fluid drainage catheterization kit
Ascenda® by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumbar cerebrospinal fluid drainage catheterization kit.
- Hermetic™ — Integra Lifesciences Corp. · Class II
- Hermetic™ — Integra Lifesciences Corp. · Class II
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- MoniTorr™ — Integra Lifesciences Corp. · Class II
- AccuDrain® External CSF Drainage System — Integra Lifesciences Corp. · Class II
- LimiTorr™ — Integra Lifesciences Corp. · Class II
- External CSF Drainage System Collection Bag — Integra Lifesciences Corp. · Class II
- MoniTorr™ — Integra Lifesciences Corp. · Class II
Cleared under the same submission
P860004 also covers:
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- Ascenda — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 0067f21e-066d-49e5-894f-798deac72cbb 37 fields · synced Jun 8, 2026