FDA.reportPublic FDA data

In-Situ Repositioning Sheet Medium

Primary DI
05056387438900
Brand
In-Situ Repositioning Sheet Medium
Company
SILVALEA LIMITED
Model
M921539-M
Published
2024-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
INESling, Overhead Suspension, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056387438900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056387438900050563874389005056387438900

GMDN Terms#

Term, Definition table
TermDefinition
Patient lifting system stretcherA lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a lying (horizontal) position for transfer and (re)positioning. It is designed as an elongated framework with a solid or soft surface upon which the person to be lifted is placed and contained during the lifting process.

Regulatory Flags#

DUNS number
423632996
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056387409245Stand Assist Clip Fixings LargeD202LRGCP2024-02-28
05056387409252Stand Assist Loop Fixings LargeD202LRGLP2024-02-28
05056387409269Stand Assist Clip Fixings MediumD202MEDCP2024-02-28
05056387409276Stand Assist Loop Fixings MediumD202MEDLP2024-02-28
05056387409283Stand Assist Clip Fixings SmallD202SMCP2024-02-28
05056387409290Stand Assist Loop Fixings SmallD202SMLP2024-02-28
05056387409306Stand Assist Clip Fixings Extra LargeD202XLRGCP2024-02-28
05056387409313Stand Assist Loop Fixings Extra LargeD202XLRGLP2024-02-28
05056387409320Stand Assist Clip Fixings Extra SmallD202XSMCP2024-02-28
05056387409337Stand Assist Loop Fixings Extra SmallD202XSMLP2024-02-28
05056387409344Stand Assist Clip Fixings Ex Ex LargeD202XXLRGCP2024-02-28
05056387409351Stand Assist Loop Fixings Ex Ex LargeD202XXLRGLP2024-02-28
05056387409368Stand Assist Loop Fixings Ex Ex Ex LargeD202XXXLRGLP2024-02-28
05056387401836Silvalea Boned Back Stand aid poly loops LARGE202GL2025-03-13
05056387401850Silvalea Boned Back Stand aid poly loops MEDIUM202GM2025-03-13
05056387401898Silvalea Boned Back Stand aid poly loops EXTRA LARGE202GXL2025-03-13
05056387439426Rachel Harness Mesh Navy XXXSmallM921535-XXXS2024-08-05
05056387439433Rachel Harness Mesh Navy XXSmallM921535-XXS2024-08-05
05056387439440Rachel Harness Mesh Navy Extra SmallM921535-XS2024-08-05
05056387439457Rachel Harness Mesh Navy SmallM921535-S2024-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056387401836Silvalea Boned Back Stand aid poly loops LARGESILVALEA LIMITEDINE2025-03-13
05056387401850Silvalea Boned Back Stand aid poly loops MEDIUMSILVALEA LIMITEDINE2025-03-13
05056387401898Silvalea Boned Back Stand aid poly loops EXTRA LARGESILVALEA LIMITEDINE2025-03-13
05056387439426Rachel Harness Mesh Navy XXXSmallSILVALEA LIMITEDINE2024-08-05
05056387439433Rachel Harness Mesh Navy XXSmallSILVALEA LIMITEDINE2024-08-05
05056387439440Rachel Harness Mesh Navy Extra SmallSILVALEA LIMITEDINE2024-08-05
05056387439457Rachel Harness Mesh Navy SmallSILVALEA LIMITEDINE2024-08-05
05056387439464Rachel Harness Mesh Navy MediumSILVALEA LIMITEDINE2024-08-05
05056387439471Rachel Harness Mesh Navy LargeSILVALEA LIMITEDINE2024-08-05
05056387439488Rachel Harness Mesh Navy Extra LargeSILVALEA LIMITEDINE2024-08-05
05056387439495In-Situ Deluxe Superfine Double Layer XXXSmallSILVALEA LIMITEDINE2024-08-05
05056387438917In-Situ Repositioning Sheet LargeSILVALEA LIMITEDINE2024-07-29
05056387438924In-Situ Repositioning Sheet Extra LargeSILVALEA LIMITEDINE2024-07-29
05056387439372Stretcher Sling Mesh SmallSILVALEA LIMITEDINE2024-07-29
05056387439389Stretcher Sling Mesh MediumSILVALEA LIMITEDINE2024-07-29
05056387439396Stretcher Sling Mesh LargeSILVALEA LIMITEDINE2024-07-29
05056387439402Stretcher Sling Mesh Extra LargeSILVALEA LIMITEDINE2024-07-29
05056387415864Disposable High Easy LOOPS LargeSILVALEA LIMITEDINE2024-03-11
05056387415871Disposable High Easy Poly LOOPS LargeSILVALEA LIMITEDINE2024-03-11
05056387415888Disposable High Easy LOOPS MEDIUMSILVALEA LIMITEDINE2024-03-11
05056387415895Disposable High Easy Poly LOOPS MediumSILVALEA LIMITEDINE2024-03-11
05056387415901Disposable High Easy LOOPS SmallSILVALEA LIMITEDINE2024-03-11
05056387415918Disposable High Easy LOOPS Extra LargeSILVALEA LIMITEDINE2024-03-11
05056387415925Disposable High Easy LOOPS Extra SmallSILVALEA LIMITEDINE2024-03-11
05056387415932Disposable High Easy LOOPS XXLargeSILVALEA LIMITEDINE2024-03-11
05056387437040Repositioning Sheet Close Weave PolyesterSILVALEA LIMITEDINE2024-02-29
05056387403823General Stand Aid Sling D-A Clips White Extra LargeSILVALEA LIMITEDINE2024-02-28
05056387405148Birthing Sling ManualSILVALEA LIMITEDINE2024-02-28
05056387409245Stand Assist Clip Fixings LargeSILVALEA LIMITEDINE2024-02-28
05056387409252Stand Assist Loop Fixings LargeSILVALEA LIMITEDINE2024-02-28