Identity
- Trade Name
- Exacta™ FDA UDI
- Generic Name
- Ventricular cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- EDMS 27795 EXACTA 100ML CATH FDA UDI
- Model / Reference
- 27795 FDA UDI
- Description
- EDMS 27795 EXACTA 100ML CATH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000333614 FDA UDI
- 510(k) Number
- K201118 FDA UDI
- FDA Product Code
- GWM FDA UDIHCA FDA UDI
- GMDN Term
- Ventricular cerebrospinal fluid drainage catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 FDA UDI882.4100 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ventricular cerebrospinal fluid drainage catheterization kit
Exacta™ by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventricular cerebrospinal fluid drainage catheterization kit.
- Hermetic™ — Integra Lifesciences Corp. · Class II
- Hermetic™ — Integra Lifesciences Corp. · Class II
- MoniTorr ICP™ Drainage Bag with Anti-Reflux Valve — Integra Lifesciences Corp. · Class II
- Integra ™ NeuroSciences Allegheny EVD System — Integra Lifesciences Corp. · Class II
- MoniTorr™ — Integra Lifesciences Corp. · Class II
- AccuDrain® External CSF Drainage System — Integra Lifesciences Corp. · Class II
- Cleveland Multiport Ventricular Catheter Set — Parker Hannifin Corp. · Class II
- LimiTorr™ — Integra Lifesciences Corp. · Class II
Cleared under the same submission
K201118 also covers:
- Exacta Pole Clamp with laser level — Medtronic PS Medical
- Exacta Pole Clamp with laser level — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic PS Medical
Sources (1)
- FDA UDI 808a2707-c52d-4e38-8602-1789f7571218 35 fields · synced May 30, 2026