FDA.reportPublic FDA data

SPLINTER OUT

Primary DI
00098108000039
Brand
SPLINTER OUT
Company
MediPoint Holdings LLC
Model
Splinter Out Kit - 28
Published
2025-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LRRFirst Aid Kit With Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00098108000039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00098108000039000981080000390981080000390098108000039

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, medicatedA convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118797353
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00098108000022Actuvate Splinter Out98108199078 ACT2023-09-29
00098108199054Splinter Out199052022-09-28
00098108199061Splinter Out 199062022-09-28
00098108199078Splinter Out199072022-09-28
00098108199559Splinter Out199502023-03-29
00650332732010Hart Medical - Normed - Splinter Out73202023-09-29
00738743224109ACME UNITED SPLINTER OUT22-4102023-09-29
00843484122499EVER READY SPLINTER OUT REMOVER 19907-ER2023-06-14
00843484122505EVER READY SPLINTER OUT REMOVER19906-ER2023-06-14
00000981080008Hart Medical - Normed - Splinter Out73202023-09-29
00098108000008Splinter Out199502023-03-29
00098108195711Medipoint Blood Lancets195702002023-02-01
00098108195728Medipoint Blood Lancets1957010002023-02-01
00098108195773Medipoint195702022-10-14
00098108195780Medipoint195712022-10-14
00098108000015Medipoint195712022-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209138890NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138906NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138913NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138920NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138944NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138951NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00050428000021CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLRR2026-05-19
00092265917841First Aid OnlyAcme United CorporationLRR2026-04-23
00020424221249BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-04-21
00713733293129MEIJERMEIJER, INC.LRR2026-04-20
00760236195603MeijerMEIJER, INC.LRR2026-04-20
00666365119704NanukNanuk Gear Protection USA Inc.LRR2026-04-16
10850015055826Trauma KitULINE, INC.LRR2026-04-06
20020424226811BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-04-02
00020424010157BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-03-31
00020424016432ESSENTIALSTOTAL RESOURCES INTERNATIONAL INC.LRR2026-03-27
00017276241334Bluey First Aid KitAso LLCLRR2026-03-03
00197344173627CURADMEDLINE INDUSTRIES, INC.LRR2026-01-23
00020424060770BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2025-11-21
00017276240931up&upTARGET CORPORATIONLRR2025-11-03
M68924105050Poolside Medical Rescue RefillSafeguard US Operating, LLCLRR2025-10-14
00092265960021First Aid OnlyAcme United CorporationLRR2025-09-30
00193489100351CURADMEDLINE INDUSTRIES, INC.LRR2025-06-02
00096295144857LEADERCardinal Health 110, Inc.LRR2025-05-13
00017276240184Crayola First Aid KitAso LLCLRR2025-02-10
00050428103623CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLRR2024-09-17
00193489081766CURADMEDLINE INDUSTRIES, INC.LRR2024-08-06
00017276237542Care Science Aso LLCLRR2024-07-08
00041260020803KrogerKROGER CO., THELRR2024-04-15
00091966043309AAALIFELINE FIRST AID, LLCLRR2024-03-11