FDA.reportPublic FDA data

Span-America

Primary DI
H93350840120
Brand
Span-America
Company
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Model
SPAN AIDS
Catalog number
50840-120
Device description
BAXTER ABD PLW LG 1.2D 2/CS (P01441)
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IOZSplint, Abduction, Congenital Hip Dislocation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOZSplint, Abduction, Congenital Hip DislocationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H93350840120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
073704413
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
H93338036Span-AmericaAPM-i380362026-04-13
H93338042Span-AmericaAPM-i380422026-04-13
H93338436Span-AmericaAPM-i384362026-04-13
H93338442Span-AmericaAPM-i384422026-04-13
H9336200Span-AmericaAPM-i62002026-04-13
H933EZ161896Span-AmericaEZ-DISHEZ1618-962026-02-26
H93392270Span-AmericaSpan Care Convertible922702026-02-25
H933P11634Span-AmericaFloor LiftP116342025-12-03
H933PR13051Span-AmericaOSKA APM2PR13-0512025-12-01
H93353893Span-AmericaGEOMATTRESS 350538932025-12-01
H93332864Span-AmericaCUSTOM CARE LAL328642025-09-09
H93355696Span-AmericaCUSTOM CARE LAL2025-09-09
H93384683Span-AmericaCUSTOM CARE LAL846832025-09-09
H93392474Span-AmericaCUSTOM CARE LAL924742025-09-09
H93331629Span-AmericaPlus316292025-09-04
H93313584Span-AmericaPlus135842025-09-04
H93335834Span-AmericaGEOMATTRESS358342025-08-04
H93338296Span-AmericaGEOMATTRESS382962025-08-04
H93350746CN16Span-AmericaGeomattress50746-CN162022-12-06
H93350077116Span-AmericaSpan Aids50077-1162022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H93350840100Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840110Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840210Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840245Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840250Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93300267100100Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267100200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267100300Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267500000Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
00645517327983TrulifeTRULIFE LIMITEDIOZ2022-12-31
00645517327990TrulifeTRULIFE LIMITEDIOZ2022-12-31
00645517328003TrulifeTRULIFE LIMITEDIOZ2022-12-31
G088DSHKOR0PanaceaBlake Manufacturing, Inc.IOZ2022-09-06
G088DSHKOS0PanaceaBlake Manufacturing, Inc.IOZ2022-09-06
G088HKOR0BMIBlake Manufacturing, Inc.IOZ2022-08-15
G088HKOS0BMIBlake Manufacturing, Inc.IOZ2022-08-15
00749756018029DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00749756018036DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00749756018043DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00889024369207N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369214N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369221N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369283N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00696588003580Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588003597Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588003795Pediatric Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588003818Universal Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588005447Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588005485Pediatric Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588006116Universal Abduction PillowInnovative Medical Products, IncIOZ2020-06-02