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Silicone Hubless Endo Drain Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 2015-9715
Identity
- Trade Name
- Fortune®Silicone Hub-less Endo Drain Kit EUDAMEDSilicone Hubless Endo Drain Kit FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Fortune®Silicone Hub-less Endo Drain Kit EUDAMED
- Model / Reference
- 2015-9715 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 14711182606111 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14711182606111 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
- Malta 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 Hubless Endo 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.
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- 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 (2)
- FDA UDI 7260621c-3c22-4697-bc3c-c18087f7a324 32 fields · synced Jul 25, 2026
- EUDAMED 04cae4b2-fe07-4e56-955b-48fd9ea5cd1f 61 fields · synced Jul 25, 2026