2.75" X 10" Practicon Sterilization Pouches

FDA UDI

Class II (US FDA UDI)

by Practicon, Inc.

Identity

Trade Name: 2.75" X 10" PRACTICON STERILIZATION POUCHES FDA UDI
Generic Name: Sterilization packaging, single-use FDA UDI
Device Name: Self-Sealing sterilization pouches with internal and external indicators. 200 per box FDA UDI
Model / Reference: 7158232 FDA UDI
Description: Self-Sealing sterilization pouches with internal and external indicators. 200 per box FDA UDI

Identifiers

Catalog Number: 7158232 FDA UDI
Primary DI / UDI-DI: 00723896026335 FDA UDI
510(k) Number: K162258 FDA UDI
FDA Product Code: FRG 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Sterilization packaging, single-use

2.75" X 10" Practicon Sterilization Pouches by Practicon, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K162258 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: Practicon, Inc.

Sources (1)

FDA UDI 6eec85d5-3a38-4115-bf5c-2f62dc9d1691 35 fields · synced May 30, 2026