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Silicone T Drainage Set With Eyes
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1910-8016Ref 1910-4005Ref 1910-4008Ref 1910-4010
Identity
- Trade Name
- Silicone T Drainage Set EUDAMEDFDA UDISilicone T Drainage Set With Eyes FDA UDI
- Generic Name
- Biliary drain FDA UDI
- Device Name
- Silicone T Drainage Set EUDAMED
- Model / Reference
- 1910-8016 EUDAMEDFDA UDI1910-4005 EUDAMEDFDA UDI1910-4008 EUDAMEDFDA UDI1910-4010 EUDAMED1910-8212 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711182613037 EUDAMEDFDA UDI04711182607425 EUDAMEDFDA UDI04711182607418 EUDAMEDFDA UDI14711182607422 EUDAMED14711182613034 EUDAMED14711182607415 EUDAMED14711182607408 EUDAMED04711182607548 FDA UDI
- Basic UDI-DI
- B-04711182613037 EUDAMEDB-04711182607425 EUDAMEDB-14711182607422 EUDAMEDB-04711182607418 EUDAMEDB-14711182613034 EUDAMEDB-14711182607415 EUDAMEDB-14711182607408 EUDAMED
- 510(k) Number
- K980917 FDA UDI
- FDA Product Code
- GCA FDA UDI
- EMDN Code
- A0601010402 CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED) EUDAMED
- GMDN Term
- Biliary drain FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biliary drain
Silicone T Drainage Set With Eyes by Fortune Medical Instrument Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K980917 also covers:
- Silicone T Drainage Set — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set With Eyes — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set With Eyes — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set With Eyes — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set With Eyes — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set With Eyes — FORTUNE MEDICAL INSTRUMENT CORP.
- Silicone T Drainage Set With Eyes — FORTUNE MEDICAL INSTRUMENT CORP.
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
Sources (11)
- FDA UDI 6ca258a4-865d-4edc-a0af-e85809f46a3d 33 fields · synced Jul 30, 2026
- FDA UDI d13c0450-4bc2-4fd6-90d8-c02bc176aed8 33 fields · synced May 29, 2026
- FDA UDI 4bcdfc5b-db31-4b04-9f0a-f05d174d2561 33 fields · synced May 30, 2026
- FDA UDI 94481887-4771-4e80-afdf-1e96690fb1d4 33 fields · synced May 30, 2026
- EUDAMED 735ac596-459e-4a2c-9fe4-bf15ba94ee8f 61 fields · synced Jul 15, 2026
- EUDAMED 67c1b2ed-f483-4464-8fd6-36f8a790b425 61 fields · synced Jul 18, 2026
- EUDAMED 5bae8407-779f-41ad-be7e-6799cd746ef1 61 fields · synced Jul 18, 2026
- EUDAMED 13032d17-f436-42aa-827f-b176772a7cb0 61 fields · synced Jul 21, 2026
- EUDAMED ea199183-f76a-4533-ac11-d7b52214986a 61 fields · synced Jul 21, 2026
- EUDAMED 7430cf26-4fa4-4496-a7c8-05a76847ca95 61 fields · synced Jul 25, 2026
- EUDAMED 9759d908-9034-4bd0-a1e8-38f64c219f55 61 fields · synced Jul 30, 2026