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Silicone T Drainage Set With Eyes

FDA UDI

Class II (US FDA UDI)

by Fortune Medical Instrument Corp.

Identity

Trade Name
Silicone T Drainage Set With Eyes FDA UDI
Generic Name
Biliary drain FDA UDI
Model / Reference
1910-8214 FDA UDI

Identifiers

Primary DI / UDI-DI
04711182606428 FDA UDI
510(k) Number
K980917 FDA UDI
FDA Product Code
GCA FDA UDI
GMDN Term
Biliary drain FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biliary drain.

Cleared under the same submission

K980917 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fortune Medical Instrument Corp.

Sources (1)

  • FDA UDI d0bb8493-0da7-4d14-8bff-8fc3a8a3c6fa 33 fields · synced May 30, 2026