Identity
- Trade Name
- DLP® FDA UDI
- Generic Name
- Pericardiocentesis needle, single-use FDA UDI
- Device Name
- SUCTION 12006 ASPIRATING NEEDLE 16GA 20P FDA UDI
- Model / Reference
- 12006 FDA UDI
- Description
- SUCTION 12006 ASPIRATING NEEDLE 16GA 20P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20613994794578 FDA UDI
- 510(k) Number
- K865079 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Pericardiocentesis needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
No
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
Dimensions & Sizes
- Size
- Needle Gauge — 16.0 Gauge FDA UDI
Category: Pericardiocentesis needle, single-use
Dlp® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pericardiocentesis needle, single-use.
- EpiAccess Needle — Epiep, Inc. · Class II
- PeriVac™ Kit — Boston Scientific · Class II
- PeriVac™ Kit — Boston Scientific · Class II
- PeriVac™ Kit — Boston Scientific · Class II
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, Inc.
Sources (1)
- FDA UDI 28d71a11-c87c-4443-aa42-e3d7fa4315f0 36 fields · synced May 31, 2026