FDA.reportPublic FDA data

Curaplex

Primary DI
00812277037401
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
14781
Catalog number
14781
Device description
Curaplex Folding Scoop Stretcher, w/Straps (Load Limit 350lb)
Published
2022-12-30
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
FPPSTRETCHER, HAND-CARRIED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPPStretcher, Hand-CarriedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277038668PackageGS11In Commercial Distribution
00812277037401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277038668008122770386688122770386680812277038668
00812277037401008122770374018122770374010812277037401

GMDN Terms#

Term, Definition table
TermDefinition
Spine boardA flat, stiff device intended to be placed under a patient (the patient is usually strapped to this device) to ensure spinal immobilization when a spinal injury is suspected. This device is often used in combination with a head/neck immobilizing device that is also typically fixed or strapped to it. It is typically used after serious accidents and for transport of the patient on a stretcher. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a reusable device.

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810071637285Curaplex301-P3050301-P3050EA2022-12-30
00810071637292CuraplexP3052EA301-P3052EA2022-12-30
00810071637308Curaplex301-P3054301-P3054EA2022-12-30
00199972000436Curaplex8600-01565-KIT8600-01565-KIT2026-08-15
00199972000443Curaplex670283-KIT670283-KIT2026-08-15
00199972000450Curaplex670284-KIT670284-KIT2026-08-15
00199972000467Curaplex8600-01567-KIT8600-01567-KIT2026-08-15
00199972000474Curaplex8600-01558-KIT8600-01558-KIT2026-08-15
00199972000528CuraplexSIVBDIO02-26-KITSIVBDIO02-26-KIT2026-08-15
00199972000535Curaplex670289-KIT670289-KIT2026-08-15
00199972000559Curaplex670290-KIT670290-KIT2026-08-15
00199972000573Curaplex670291-KIT670291-KIT2026-08-15
00810094578053Curaplex®SIVBDIO01-24-KITSIVBDIO01-24-KIT2026-07-30
00199972000504Curaplex8600-015668600-015662026-07-17
00810094575809Curaplex680152-KIT680152-KIT2023-04-30
00815277028059Curaplex8600-ATFMLOK2016-12-14
00815277029377Curaplex680150-KIT680150-KIT2018-12-15
01999720000003Curaplex Advanced Hemostatic Gauze4in x 4in(10cm x 10cm)CAHG-4X42025-11-25
01999720000027Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-11-25
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25

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Primary DI, Brand, Company table
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