Lucky Super Soft

Primary DI
00808829129083
Brand
Lucky Super Soft
Company
DELTA BRANDS INC.
Model
Extra Large Plastic Bandages
Device 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
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00808829129083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00808829129083008088291290838088291290830808829129083

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cover adhesive strip, non-antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
102672008
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00808829132373PERSONAL CARETest midstream I2026-10-16
00808829131321Lucky Super SoftCooling Relief Soft Gel Sheets2026-07-10
00808829131185Lucky Super SoftLarge Plastic Bandages2026-04-10
00808829130980Lucky Super SoftExtra Large Plastic Bandages2026-03-27
00808829130706Lucky Super SoftFlex Fabric Bandages2026-02-13
00808829127065Lucky Super SoftBandages in differenet size2024-05-10
00808829125672CLARISSETest midstream I2024-03-07
00808829124170Lucky Super SoftBandages In Different Size2023-08-25
00048155920200Personal CareCassette2018-05-11
00808829120615ClarisseMidstream2022-03-25
00808829120028Personal Care120022021-08-27
00808829111903ClarisseCassette2017-11-17
00808829120325Lucky Super SoftBandages in different sizes2023-02-17
00808829119695Lucky Super SoftBandages in differenet size2022-12-16
00808829041002Lucky Super SoftBandages in differenet size2022-12-13
00808829102536Lucky Super SoftKit2022-12-13
00808829121612Personal CareCassette2022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00050428142677CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428143124CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340936CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428341308CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342053CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342121CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342602CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428346396CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428347133CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
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08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
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