FDA.reportPublic FDA data

Welly

Primary DI
00810010440198
Brand
Welly
Company
WELLY HEALTH PBC
Model
WLY1020
Device description
Scissors, Tweezers & Clippers
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00810010440198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810010440198008100104401988100104401980810010440198

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-239-3559hello@getwelly.com

Regulatory Flags#

DUNS number
116766884
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00372663000018WellyWLY10382020-09-01
00372663000056WellyWLY10432020-09-01
00372663000063WellyWLY10442020-09-01
00372663000100WellyWLY10542020-09-01
00372663000117WellyWLY1014C2020-09-01
00372663000315WellyWLY1013C2020-09-01
00372663120143WellyWLY10132020-09-01
00372663130234WellyWLY10142020-09-01
00372663171053WellyWLY10272020-09-01
00810010440006WellyWLY10012020-09-01
00810010440013WellyWLY10022020-09-01
00810010440020WellyWLY10032020-09-01
00810010440037WellyWLY10042020-09-01
00810010440044WellyWLY10052020-09-01
00810010440051WellyWLY10062020-09-01
00810010440068WellyWLY10072020-09-01
00810010440075WellyWLY10082020-09-01
00810010440082WellyWLY10092020-09-01
00810010440099WellyWLY10102020-09-01
00810010440105WellyWLY10112020-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00842209140411NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140428NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140435NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140442NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140466NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140473NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140480NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140497NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140510NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140565NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140572NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140589NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00199972000801CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000825CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000849CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000863CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000887CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000900CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00842209140169NARNORTH AMERICAN RESCUE, LLCOHO2026-09-28
00842209140176NARNORTH AMERICAN RESCUE, LLCOHO2026-09-28
00842209140237NARNORTH AMERICAN RESCUE, LLCOHO2026-09-28
00842209140312NARNORTH AMERICAN RESCUE, LLCOHO2026-09-28
00842209140329NARNORTH AMERICAN RESCUE, LLCOHO2026-09-28
00842209140336NARNORTH AMERICAN RESCUE, LLCOHO2026-09-28
00842209140343NARNORTH AMERICAN RESCUE, LLCOHO2026-09-28