Identity
- Trade Name
- Becker FDA UDI
- Generic Name
- Ventricular cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- EDMS 27811 BECKER GRN PL VCATH FDA UDI
- Model / Reference
- 27811 FDA UDI
- Description
- EDMS 27811 BECKER GRN PL VCATH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000572921 FDA UDI
- 510(k) Number
- K984053 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Ventricular cerebrospinal fluid drainage catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 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
Becker by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ventricular cerebrospinal fluid drainage catheterization kit.
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- 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
K984053 also covers:
- Becker — Medtronic PS Medical
- Becker — Medtronic PS Medical
- Becker — Medtronic PS Medical
- Becker — Medtronic PS Medical
- Becker — Medtronic PS Medical
- Becker — Medtronic PS Medical
- Becker — Medtronic PS Medical
- Becker System — Medtronic PS Medical
- Becker® — Medtronic PS Medical
- Becker® — Medtronic PS Medical
- Becker® — Medtronic PS Medical
- Becker® — 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 7e9ea5f2-b4de-410a-9f28-bd84911c7230 35 fields · synced May 31, 2026