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Silicone Hubless Endo Drain Kit (J Connector+Trocar)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 2015-0710JRef 2015-0719JRef 2015-9710JRef 2015-9719Ref 2015-0715J
Identity
- Trade Name
- Silicone Hub-less Endo Drain Tube + J Connector EUDAMEDFortune® Silicone Hub-less Endo Drain Tube + J Connector EUDAMEDSilicone Hub-less Endo Drain Kit EUDAMEDSilicone Hubless Endo Drain Kit (J Connector+Trocar) FDA UDISilicone Hubless Endo-Drain Tube+J connector FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Silicone Hub-less Endo Drain Tube + J Connector EUDAMEDFortune® Silicone Hub-less Endo Drain Tube + J Connector EUDAMEDSilicone Hub-less Endo Drain Kit EUDAMED
- Model / Reference
- 2015-9710J EUDAMEDFDA UDI2015-0715J EUDAMEDFDA UDI2015-0710J EUDAMEDFDA UDI2015-0719J EUDAMED2015-9719 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14711182606609 EUDAMEDFDA UDI14711182606470 EUDAMEDFDA UDI04711182606473 EUDAMED04711182606497 EUDAMED04711182606121 EUDAMED04711182606480 EUDAMED14711182606487 FDA UDI
- Basic UDI-DI
- B-04711182606473 EUDAMEDB-04711182606497 EUDAMEDB-14711182606609 EUDAMEDB-14711182606470 EUDAMEDB-04711182606121 EUDAMEDB-04711182606480 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 EUDAMEDBelgium EUDAMEDPoland 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 (J Connector+Trocar) by Fortune Medical Instrument Corp. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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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 (9)
- FDA UDI 07fbdeaf-872e-4997-b6b9-9ed6df458435 32 fields · synced Aug 3, 2026
- FDA UDI 7c032a83-0d60-4164-b3d8-7a4ec02d459f 32 fields · synced May 25, 2026
- FDA UDI 9b662cd9-632a-400b-bb0d-7e3efa4c876c 32 fields · synced May 30, 2026
- EUDAMED 6a8d5ebd-db9b-4f47-9c98-7a5fb044dcd9 61 fields · synced Jul 9, 2026
- EUDAMED 1d289e6d-87d2-49be-8abd-26f5f54ac2bf 61 fields · synced Jul 11, 2026
- EUDAMED 63dfc081-35ef-48e2-a24f-f25e0ed13b36 61 fields · synced Jul 12, 2026
- EUDAMED ffdfddd4-d05c-4aa7-a7ae-dfc2586614a1 61 fields · synced Jul 24, 2026
- EUDAMED e490a607-cee9-40ad-92a8-fdb27a4d6a78 61 fields · synced Jul 27, 2026
- EUDAMED ee2c7c0c-3605-48a5-9417-a57cfadea735 61 fields · synced Aug 3, 2026