FDA.reportPublic FDA data

EVERLIT CARE

Primary DI
00810173051675
Brand
EVERLIT CARE
Company
Everlit Global Inc.
Model
CARE_SPLINTKIT
Device description
Splint Kit
Published
2026-10-09
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810173051675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810173051675008101730516758101730516750810173051675

GMDN Terms#

Term, Definition table
TermDefinition
First aid limb splint, mouldable, reusableA portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It takes the form of a semi-rigid, padded, metallic sheet, or a wire frame, designed to be manually moulded/curved externally around the limb to create a rigid splint. It is typically intended to be used by emergency medical services (EMS). This is a reusable device.

Regulatory Flags#

DUNS number
122311450
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810173051705EVERLIT CARECARE_FATP_122026-10-20
00850061187000EVERLITESFAK-BLK2026-10-12
00850061187017EVERLITESFAK-TAN2026-10-12
00850061187031EVERLITESFAK-BCAMO2026-10-12
00850061187055EVERLITESFAK-OD2026-10-12
00810173051330EVERLITBITE-KIT2026-10-07
00810173051996EVERLIT CARECARE_POST25_102026-10-07
00810173051019EVERLITRUTK-BLK2026-09-30
00810173051460EVERLIT CARE202SFAK-502026-09-30
00810173051699EVERLIT CARE203SFAK-1002026-09-30
00850061187185EVERLITIB-22026-09-28
00850061187192EVERLITIB-32026-09-28
00850061187208EVERLITIB-52026-09-28
00850061187215EVERLITIB-102026-09-28
00810173050401EVERLIT CARECARE_POFAK482026-09-22
00810173050418EVERLIT CARECARE_POFAK242026-09-22
00810173050425EVERLIT CARECARE_POFAK122026-09-22
00810173051316EVERLIT CARECFAK-252026-09-22
00810173051323EVERLIT CARECARE_FATP_122026-09-22
00810173051644EVERLIT CARECARE_KFATP_102026-09-22