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Silicone Flat Drain Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref PR2014-9102Ref CO2014-9101Ref PR2014-9072Ref CO2014-9072Model CO2014-9102Ref 2014-9052Ref PR2014-9101
Identity
- Trade Name
- Silicone Flat Drain Kit EUDAMEDFDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Silicone Flat Drain Kit EUDAMED
- Model / Reference
- 2014-9052 EUDAMEDFDA UDIPR2014-9102 EUDAMEDCO2014-9101 EUDAMEDPR2014-9072 EUDAMEDCO2014-9102 EUDAMEDCO2014-9072 EUDAMEDPR2014-9101 EUDAMED2014-9072 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14710961935046 EUDAMEDFDA UDI14711182605053 EUDAMED14711182606203 EUDAMED04711182605032 EUDAMED04710961937821 EUDAMED04710961935049 EUDAMED04711182605049 EUDAMED14711182605046 EUDAMED14710961935060 FDA UDI
- Basic UDI-DI
- B-14711182605053 EUDAMEDB-14711182606203 EUDAMEDB-04711182605032 EUDAMEDB-04710961937821 EUDAMEDB-04710961935049 EUDAMEDB-04711182605049 EUDAMEDB-14710961935046 EUDAMEDB-14711182605046 EUDAMED
- FDA Product Code
- GCD FDA UDI
- EMDN Code
- A0601010403 FLAT AND LAMELLAR DRAINAGES EUDAMED
- GMDN Term
- Closed-wound drain, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Italy EUDAMEDSpain EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Closed-wound drain, non-bioabsorbable
Silicone Flat Drain Kit by Fortune Medical Instrument Corp. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound drain, non-bioabsorbable.
- Argyle — Cardinal Health 200, LLC · Class II
- ReSolve® — Merit Medical Systems, Inc. · Class I
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Argyle — Cardinal Health 200, LLC · Class II
- Silicone Vac Drain, Round — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
- SKATER™ Mini-Loop Drainage Set — Argon Medical Devices, Inc. · Class I
- Drainage Tube and Accessories — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- Exodus — NAVILYST MEDICAL, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
Sources (10)
- FDA UDI c93933ce-68db-4cee-bf80-04c0d8fd54f6 32 fields · synced Sep 30, 2026
- FDA UDI a42564ea-39df-4b6c-a698-68993c4e3132 32 fields · synced May 30, 2026
- EUDAMED 06cd0a5d-c011-4510-9c37-e422fbf2ae7e 61 fields · synced Jul 9, 2026
- EUDAMED 46752052-36c1-42f1-9a6f-67887e6473ba 61 fields · synced Jul 10, 2026
- EUDAMED 1e1c7a6d-800c-4a4c-be7d-e1a9aa1e6858 61 fields · synced Jul 11, 2026
- EUDAMED a6190e3c-25cb-4a48-a89c-886035df4ca1 61 fields · synced Jul 21, 2026
- EUDAMED ea50d808-e96f-4da7-b2e8-5d3a6faff8aa 61 fields · synced Jul 21, 2026
- EUDAMED b213d17e-d7a0-4d55-bab5-d305df1671b7 61 fields · synced Jul 28, 2026
- EUDAMED a6d6382b-4067-4695-b9c0-c7ef3bd2e0cf 61 fields · synced Jul 29, 2026
- EUDAMED 5a0008f2-4b7c-4abe-876b-a0d2cc5a0162 61 fields · synced Aug 2, 2026