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ProSeal CSTD

FDA UDI

Class II (US FDA UDI)

by Epic International(thailand) Company Limited

Identity

Trade Name
ProSeal CSTD FDA UDI
Generic Name
Vial/bottle adaptor, hermetic FDA UDI
Device Name
ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 20 mm Vial FDA UDI
Model / Reference
420700 FDA UDI
Description
ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 20 mm Vial FDA UDI

Identifiers

Primary DI / UDI-DI
18859299130702 FDA UDI
510(k) Number
K241476 FDA UDI
FDA Product Code
ONB FDA UDI
GMDN Term
Vial/bottle adaptor, hermetic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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: Vial/bottle adaptor, hermetic

ProSeal CSTD by Epic International(thailand) Company Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vial/bottle adaptor, hermetic.

Cleared under the same submission

K241476 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epic International(thailand) Company Limited

Sources (1)

  • FDA UDI e777c0c3-6a63-49bd-bf65-0c002ff890a8 34 fields · synced May 30, 2026