FDA.reportPublic FDA data

LUCKY SUPER SOFT

Primary DI
00808829132403
Brand
LUCKY SUPER SOFT
Company
DELTA BRANDS INC.
Model
FIRST AID KIT
Device description
A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Published
2026-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00808829132403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00808829132403008088291324038088291324030808829132403

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
102672008
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
true
No natural rubber latex
false
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
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
00808829102536Lucky Super SoftKit2022-12-13
00808829121612Personal CareCassette2022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M689WJBBC300000050Bleeding Control Kit 3-Pcs in med kit box w/ bracket 6/csSafeguard US Operating, LLCOHO2026-11-05
00842209140596NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140602NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140619NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140633NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140640NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140657NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
06942509220593OP - First aid seriesdata:image/svg+xml,%3csvg%20xmlns='http://www.w3.org/2000/Yiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220609OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220616OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220623OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
00850070635226Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635257Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635264Pro Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635288Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635295Response Plus kitNar Medical Depot, LLCOHO2026-10-23
00850070635318Pro Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635356RESPONSE KITNar Medical Depot, LLCOHO2026-10-23
06942509220647OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220708OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220715OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220722OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220890OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509221217OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
M6898723101040Bleeding Control KitSafeguard US Operating, LLCOHO2026-10-22
M68981601030Rant Strategies K9 Trauma KitSafeguard US Operating, LLCOHO2026-10-20
00842209140367NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140374NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140398NAR KitNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140404NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14