Winged Needle Infusion Set

FDA UDI

Class U (US FDA UDI)

by Sientra, Inc.

Identity

Trade Name: Winged Needle Infusion Set FDA UDI
Generic Name: Skin-port tissue expander FDA UDI
Device Name: 21 Ga. Winged Needle Infusion Set (5 each) FDA UDI
Model / Reference: WNIS01 FDA UDI
Description: 21 Ga. Winged Needle Infusion Set (5 each) FDA UDI

Identifiers

Catalog Number: WNIS01 FDA UDI
Primary DI / UDI-DI: 00819409020355 FDA UDI
510(k) Number: K140383 FDA UDI
FDA Product Code: LCJ FDA UDI
GMDN Term: Skin-port tissue expander FDA UDI

Classification

Device Class: U 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Skin-port tissue expander

Winged Needle Infusion Set by Sientra, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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 U	Pending data

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Manufacturer

Manufacturer: Sientra, Inc.

Sources (1)

FDA UDI fce0c706-837a-435c-b614-c974d96bab6a 37 fields · synced Jun 8, 2026