FDA.reportPublic FDA data

Span-America

Primary DI
H933SP22S200
Brand
Span-America
Company
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Model
Convoluted Rollpack
Catalog number
SP22S-200
Device description
CONVOLUTED PAD
Published
2022-12-07
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
KICCushion, Flotation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H933SP22S200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient pressure distribution pad, single-useA cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H93383478Span-AmericaULTRAMAX834782026-07-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344014347MEDLINEMEDLINE INDUSTRIES, INC.KIC2026-05-08
00613732114824ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114831ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114848ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114855ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114862ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114879ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114886ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114893ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114909ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114916ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114923ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114930ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114947ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114954ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114961ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114978ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114985ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114992ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115005ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115012ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115029ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115036ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115043ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115050ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115067ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115074ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115081ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115098ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115104ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09