Fascile Continuous Peripheral Nerve Block Set

FDA UDI

Class II (US FDA UDI)

by Solo-Dex, Inc

Identity

Trade Name: Fascile Continuous Peripheral Nerve Block Set FDA UDI
Generic Name: Peripheral nerve-block sharp needle FDA UDI
Device Name: Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure. FDA UDI
Model / Reference: 70mm, Kit without filter FDA UDI
Description: Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure. FDA UDI

Identifiers

Catalog Number: 500001-02 FDA UDI
Primary DI / UDI-DI: B372500001021 FDA UDI
510(k) Number: K151072 FDA UDI
FDA Product Code: BSP FDA UDI
GMDN Term: Peripheral nerve-block sharp needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Dimensions & Sizes

Size: Length — 70 Millimeter FDA UDI

Category: Peripheral nerve-block sharp needle

Fascile Continuous Peripheral Nerve Block Set by Solo-Dex, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K151072 also covers:

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: Solo-Dex, Inc

Sources (1)

FDA UDI 6f1de0a4-0398-41ba-8b0b-f281a1f01082 37 fields · synced May 31, 2026