Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz Tube

FDA UDI

Class I (US FDA UDI)

by Kericure Inc.

Identity

Trade Name: Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz Tube FDA UDI
Generic Name: Skin semi-occlusive dressing, antimicrobial FDA UDI
Device Name: Advanced Shield Hydrogel Wound Barrier with Silver Hydrosol, 2oz GEL Tube FDA UDI
Model / Reference: 6041220 FDA UDI
Description: Advanced Shield Hydrogel Wound Barrier with Silver Hydrosol, 2oz GEL Tube FDA UDI

Identifiers

Primary DI / UDI-DI: 00858071004348 FDA UDI
FDA Product Code: NAE FDA UDI
GMDN Term: Skin semi-occlusive dressing, antimicrobial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4022 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

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Skin semi-occlusive dressing, antimicrobial

Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz Tube by Kericure Inc. — 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: Kericure Inc.

Sources (1)

FDA UDI 08ac62ca-9711-4033-8b65-8248c092f3b7 33 fields · synced May 30, 2026