Identity
- Trade Name
- Intracardiac Sucker FDA UDI
- Generic Name
- Suction system catheter, general-purpose FDA UDI
- Model / Reference
- S352-80 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033178004497 FDA UDI
- 510(k) Number
- K900339 FDA UDI
- FDA Product Code
- DTS FDA UDI
- GMDN Term
- Suction system catheter, general-purpose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4420 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suction system catheter, general-purpose
Intracardiac Sucker by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suction system catheter, general-purpose.
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- Gen2 — SURGIX MEDICAL LLC · Class II
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- Gen2 — SURGIX MEDICAL LLC · Class II
- GP General Purpose Drainage Catheter — Uresil Corp. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
- Gen2 — SURGIX MEDICAL LLC · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
Cleared under the same submission
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
- Sorin Group Italia Srl
Sources (1)
- FDA UDI ff7522bb-7d6b-4b86-b1dc-893e7c270dbd 33 fields · synced May 30, 2026