FDA.reportPublic FDA data

Redicare

Primary DI
B70903050060
Brand
Redicare
Company
REDICARE LLC
Model
Redisplint Conforming Splint
Catalog number
0305006
Device description
"4.25"" x 24"" Padded Aluminum Conforming Splint"
Published
2020-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
B70903050061PackageHIBCC200In Commercial Distribution
B70903050060PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Inch
Width4.25Inch

Regulatory Flags#

DUNS number
800149346
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B70901070010Redicare"Instant Ice Pack 4"" x 5"""01070012020-07-28
B70901070040Redicare"Instant Ice Pack 5"" x 8"""01070042020-07-28
B70901040251Redicare"Sterile Pads 3"" x 3"""01040252020-07-28
B70901040341Redicare"Non Adherent Pad 2"" x 3"""01040342020-07-28
B70901020180RedicareResuscitation Kit01020182020-07-28
B70901020760RedicareResuscitation Kit01020762020-07-28
B70901130700RedicareArterial Tourniquet with Windlass01130702022-04-28
B70903030130RedigloveNitrile Examination Glove03030132022-04-28
B70903030131RedigloveNitrile Examination Glove03030132022-04-28
B70901140070Redicare"Burn Gel Dressing 4"" x 4"""01140072020-07-28
B70901140080Redicare"Burn Gel Dressing 4"" x 4"""01140082020-08-25
B70901140081RedicareBurn Gel Dressing 4" x 4"01140082020-08-25
B70901030021RedicarePlastic Bandages Wide Strips01030022020-07-28
B70901030041RedicareFabric Wide Strip Bandage01030042020-07-28
B70901030071RedicareFabric Knuckle Bandage01030072020-07-28
B70901030131RedicareFingertip XL Fabric Bandage01030132020-07-28
B70901030161RedicareLarge Patch Fabric Bandages01030162020-07-28
B70901030171RedicareSuper Large Patch Fabric Bandages01030172020-07-28
B70901030221RedicareJunior Strip Fabric Bandages01030222020-07-28
B70901040100RedicareCohesive Flex Bandage01040102020-07-28

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Primary DI, Brand, Company table
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