PureLife Dental

FDA UDI

Class II (US FDA UDI)

by Purelife, Llc

Identity

Trade Name: PureLife Dental FDA UDI
Generic Name: Sterilization packaging, single-use FDA UDI
Device Name: 2 3/4" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink FDA UDI
Model / Reference: 1190102 FDA UDI
Description: 2 3/4" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink FDA UDI

Identifiers

Catalog Number: 1190102 FDA UDI
Primary DI / UDI-DI: D79011901021 FDA UDI
FDA Product Code: KCT FDA UDI
GMDN Term: Sterilization packaging, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6850 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Sterilization packaging, single-use

PureLife Dental by Purelife, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Arjo Wiggins Medical, Inc. — Sterimed, Inc. · Class II
Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II

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: Purelife, Llc

Sources (1)

FDA UDI 6aec37e9-4ac7-4bab-9538-4e00112160de 37 fields · synced Jun 8, 2026