Lucky Super Soft

FDA UDI

Class I (US FDA UDI)

by Delta Brands Inc.

Identity

Trade Name: Lucky Super Soft FDA UDI
Generic Name: First aid kit, non-medicated, single-use FDA UDI
Device Name: First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. FDA UDI
Model / Reference: Kit FDA UDI
Description: First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. FDA UDI

Identifiers

Primary DI / UDI-DI: 00808829102536 FDA UDI
FDA Product Code: OHO FDA UDI
GMDN Term: First aid kit, non-medicated, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4014 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: First aid kit, non-medicated, single-use

Lucky Super Soft by Delta Brands 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: Delta Brands Inc.

Sources (1)

FDA UDI 5b590c53-f846-4321-b354-f8b7586ea1bd 33 fields · synced Jun 8, 2026