FDA.reportPublic FDA data

IsoFlex LAL

Primary DI
07613327286779
Brand
IsoFlex LAL
Company
STRYKER CORPORATION
Model
2860
Catalog number
2860-000-021
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IOQBED, FLOTATION THERAPY, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327286779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327286779076133272867797613327286779

GMDN Terms#

Term, Definition table
TermDefinition
Gel-filled bed mattressA large, durable, fabric case filled with various densities of foam that support a gel structure, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327694796Broadway 8BRW084128-01BRW084128-012026-10-27
07613327141771SpinePlex040622200004062220002016-09-23
07613154355563Discmonitor040729000004072900002016-09-23
07613154358335MixEvac02060200000206-020-0002018-09-24
07613154687152AutoPlex, VertaPlex06056850000605-685-0002016-12-29
07613154687169AutoPlex, VertaPlex06056870000605-687-0002016-12-29
07613252018315PCD, VertaPlex05075890000507-589-0002016-12-29
07613252039259AutoPlex, VertaPlex06076870000607-687-0002017-01-03
07613252648642VertePort X4 Manifold060541150006054115002018-09-24
07613252648659VertePort X4 Manifold060540850006054085002018-09-24
07613252648888VertePort X4 Manifold060541000006054100002018-09-24
07613252648895VertePort X4 Manifold060540800006054080002018-09-24
07613252648901VertePort X4 Manifold060541050006054105002018-09-24
07613252648918VertePort X4 Manifold060541100006054110002018-09-24
07613327357851PCD, VertaPlex05075860000507-586-0002017-04-21
03760253800532SpineJack09094005000909-400-5002020-07-27
03760253800549SpineJack09094004000909-400-4002020-07-27
03760253800556SpineJack09093005000909-300-5002020-07-27
03760253800563SpineJack09093004000909-300-4002020-07-27
04546540039637BioPrep02067100000206-710-0002015-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00670482001132oneNEST MUmano Medical IncIOQ2026-07-31
08592654621790Multicare XL I N E T spol. s r.o.IOQ2026-07-17
00670482001019oneNEST MUmano Medical IncIOQ2026-04-24
00670482001026oneNEST MUmano Medical IncIOQ2026-04-24
00887761976870pro+HILL-ROM, INC.IOQ2026-04-21
00887761007536pro+HILL-ROM, INC.IOQ2026-04-20
00887761007543pro+HILL-ROM, INC.IOQ2026-04-20
00887761976863pro+HILL-ROM, INC.IOQ2026-04-20
00887761976887pro+HILL-ROM, INC.IOQ2026-04-20
00887761007666pro+HILL-ROM, INC.IOQ2026-03-27
00887761007697pro+HILL-ROM, INC.IOQ2026-03-27
00887761007703pro+HILL-ROM, INC.IOQ2026-03-27
00887761007505pro+HILL-ROM, INC.IOQ2026-03-25
00887761007512pro+HILL-ROM, INC.IOQ2026-03-25
00887761007550pro+HILL-ROM, INC.IOQ2026-03-25
00887761007567pro+HILL-ROM, INC.IOQ2026-03-25
00887761007581pro+HILL-ROM, INC.IOQ2026-03-25
00887761007598pro+HILL-ROM, INC.IOQ2026-03-25
00887761007604pro+HILL-ROM, INC.IOQ2026-03-25
00887761007611pro+HILL-ROM, INC.IOQ2026-03-25
00887761007628pro+HILL-ROM, INC.IOQ2026-03-25
00887761007635pro+HILL-ROM, INC.IOQ2026-03-25
00887761007642pro+HILL-ROM, INC.IOQ2026-03-25
00887761007659pro+HILL-ROM, INC.IOQ2026-03-25
08592654562703Multicare XL I N E T spol. s r.o.IOQ2026-01-07
08592654550441MulticareL I N E T spol. s r.o.IOQ2025-12-22
08592654510407MulticareL I N E T spol. s r.o.IOQ2025-05-26