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Defend

FDA UDI

Class II (US FDA UDI)

by Young Innovations, Inc.

Identity

Trade Name
Defend FDA UDI
Generic Name
Sterilization container liner FDA UDI
Device Name
Disposable Sterilization Wrap (CSR) 30 Inch x 30 Inch FDA UDI
Model / Reference
SW-3000 FDA UDI
Description
Disposable Sterilization Wrap (CSR) 30 Inch x 30 Inch FDA UDI

Identifiers

Catalog Number
SW-3000 FDA UDI
Primary DI / UDI-DI
00843471131725 FDA UDI
510(k) Number
K143637 FDA UDI
FDA Product Code
FRG FDA UDI
GMDN Term
Sterilization container liner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Defend by Young Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K143637 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Young Innovations, Inc.

Sources (1)

  • FDA UDI 07daf670-84e4-47d3-bbef-935654fe74f8 37 fields · synced Jun 8, 2026