PremierPro

FDA UDI

Class I (US FDA UDI)

by Svs Llc

Identity

Trade Name: PremierPro FDA UDI
Generic Name: Surgical cap, single-use FDA UDI
Device Name: PremierPro Bouffant Cap Lightweight, White, 24", 100/bx FDA UDI
Model / Reference: 2161 FDA UDI
Description: PremierPro Bouffant Cap Lightweight, White, 24", 100/bx FDA UDI

Identifiers

Catalog Number: 2161 FDA UDI
Primary DI / UDI-DI: 00854344002950 FDA UDI
FDA Product Code: FYF FDA UDI
GMDN Term: Surgical cap, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical cap, single-use

PremierPro by Svs Llc — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Svs Llc

Sources (1)

FDA UDI bdf5add5-f8c8-4e9d-9515-2d2141dfc4a2 35 fields · synced May 30, 2026