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Lucky Super Soft

FDA UDI

Class I (US FDA UDI)

by Delta Brands Inc.

Identity

Trade Name
Lucky Super Soft FDA UDI
Generic Name
Skin-cover adhesive strip, non-antimicrobial FDA UDI
Device Name
First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. 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
Bandages in differenet size FDA UDI
Description
First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. 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
00808829041002 FDA UDI
FDA Product Code
KGX FDA UDI
GMDN Term
Skin-cover adhesive strip, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

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: Skin-cover adhesive strip, non-antimicrobial

Lucky Super Soft by Delta Brands Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin-cover adhesive strip, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Delta Brands Inc.

Sources (1)

  • FDA UDI 0ad87e9b-3667-40e8-916f-dfbdd9c83028 33 fields · synced May 30, 2026