FDA.reportPublic FDA data

Lucky Super Soft

Primary DI
00808829102536
Brand
Lucky Super Soft
Company
DELTA BRANDS INC.
Model
Kit
Device 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.
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00808829102536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00808829102536008088291025368088291025360808829102536

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. 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
00808829131185Lucky Super SoftLarge Plastic Bandages2026-04-10
00808829130980Lucky Super SoftExtra Large Plastic Bandages2026-03-27
00808829130706Lucky Super SoftFlex Fabric Bandages2026-02-13
00808829129083Lucky Super SoftExtra Large Plastic Bandages2025-07-09
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
00808829121612Personal CareCassette2022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696295260THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
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00049696295284THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295291THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295307THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295314THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
06953395551029JINGDIJINHUA JINGDI MEDICAL SUPPLIES CO.,LTDOHO2026-06-05
06975675784682Rhino RescueEMSRUN GROUPOHO2026-06-01
06975675788093Rhino RescueEMSRUN GROUPOHO2026-06-01
06975675788109Rhino RescueEMSRUN GROUPOHO2026-06-01
M6898143003020Maritime Boat Box - AdvancedSafeguard US Operating, LLCOHO2026-05-28
00842209138760NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
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00842209138784NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138791NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138807NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138814NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138821NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138838NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138845NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138852NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138869NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138876NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138883NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138937NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138968NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138975NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
M6898444601190Mojo Multi Mission - AdvancedSafeguard US Operating, LLCOHO2026-05-27
B54133311420IFAKFARETEC, INC.OHO2026-05-12
00842209138678NARNORTH AMERICAN RESCUE, LLCOHO2026-05-12