FDA.reportPublic FDA data

Redi Splint

Primary DI
B54112113210
Brand
Redi Splint
Company
FARETEC, INC.
Model
Redi Universal Splint
Catalog number
1211321
Device description
Redi Universal Splint, Small, Olive Drab, Flat. Moldable first aid splint.
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOCSplint, Extremity, Non-Inflatable, External, Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B54112113210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
First aid limb splint, mouldable, single-useA 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, or a thermoplastic material 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 single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-350-9510colleen@faretec.com

Regulatory Flags#

DUNS number
626802540
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B54133311420IFAKUNICEF IFAK KIT33311422026-05-12
B54133311410IFAKIFAK LOT 4 33311412026-01-12
B54133311400IFAKIFAK 51 (Ind. First Aid Kit)33311402025-06-19
B54133311390IFAKIFAK 5033311392025-04-18
B54133311380IFAKIFAK 4933311382025-03-28
B54133311370IFAKIFAK 4833311372025-03-14
B54133310470IFAKCombat Casualty IFAK (DLIFAK)33310472025-02-26
B54133311360IFAKIFAK 4733311362025-01-31
B54170019070IFAKTactical Medical Kit, Backpack70019072025-01-31
B54170019080IFAKTactical Medical Bag-Component70019082025-01-31
B54133311350IFAKIFAK 4633311352024-12-11
B54133311340IFAKUN IFAK Advanced Lot 3 Plus33311342024-12-04
B54133311320IFAKIFAK Kit Advanced33311322024-06-14
B54133311310IFAKIFAK 4433311312024-06-10
B54133311300IFAKUN IFAK Advanced33311302024-05-09
B54180030080Pelvic BinderPelvic Binder, Coyote Brown80030082024-02-28
B54133311280IFAKIFAK 4333311282024-01-26
B54133311250IFAKIFAK 4033311252023-12-20
B54133311260IFAKIFAK 4133311262023-12-20
B54133311270IFAKIFAK 4233311272023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003753694KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753717KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753731KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753755KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753854KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753878KENAFLEXX KENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753892KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753915KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753533KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753557KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753571KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753595KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753618KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753632KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753656KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753670KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753779KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753793KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753816KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753830KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00609271040021Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040038Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040045Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040229Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040236Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040243Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040007Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22
00609271040014Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22
00609271040052Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22
00609271040069Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22