Skater™ Biliary Drainage Catheter Non-Locking

FDA UDI

Class II (US FDA UDI)

by Argon Medical Devices, Inc.

Identity

Trade Name: Skater™ Biliary Drainage Catheter Non-Locking FDA UDI
Generic Name: Biliary drain FDA UDI
Device Name: Skater™ Biliary Drainage Catheter Non-Locking ( 8 Fr x 40 cm) FDA UDI
Model / Reference: 8 Fr x 40 cm FDA UDI
Description: Skater™ Biliary Drainage Catheter Non-Locking ( 8 Fr x 40 cm) FDA UDI

Identifiers

Catalog Number: 755208040 FDA UDI
Primary DI / UDI-DI: 00886333001347 FDA UDI
FDA Product Code: FGE 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Biliary drain

Skater™ Biliary Drainage Catheter Non-Locking by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Argon Medical Devices, Inc.

Sources (1)

FDA UDI 4caf24d4-be9e-45e6-b07e-cdfe8bddc2d0 36 fields · synced Jun 9, 2026