FDA.reportPublic FDA data

High Easy Poly D-Ansermed Clip Ex Ex Large

Primary DI
05056387416502
Brand
High Easy Poly D-Ansermed Clip Ex Ex Large
Company
SILVALEA LIMITED
Model
M921515-XXL
Published
2024-02-26
Public version status
New
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
05056387416502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056387416502050563874165025056387416502

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient lifting system sling/harnessA general-purpose 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 sitting position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.

Sterilization Methods#

Method table
Method

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
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
05056387439464Rachel Harness Mesh Navy MediumM921535-M2024-08-05
05056387439471Rachel Harness Mesh Navy LargeM921535-L2024-08-05
05056387439488Rachel Harness Mesh Navy Extra LargeM921535-XL2024-08-05
05056387439495In-Situ Deluxe Superfine Double Layer XXXSmallM921536-XXXS2024-08-05
05056387439501In-Situ Deluxe Superfine Double Layer XXSmallM921536-XXS2024-08-05
05056387439518In-Situ Deluxe Superfine Double Layer Extra SmallM921536-XS2024-08-05
05056387439525In-Situ Deluxe Superfine Double Layer SmallM921536-S2024-08-05
05056387439532In-Situ Deluxe Superfine Double Layer MediumM921536-M2024-08-05
05056387439549In-Situ Deluxe Superfine Double Layer LargeM921536-L2024-08-05
05056387439556In-Situ Deluxe Superfine Double Layer Extra LargeM921536-XL2024-08-05
05056387439563Tinkham Sling Superfine Plus XXSmallM921537-XXS2024-08-05
05056387439570Tinkham Sling Superfine Plus Extra SmallM921537-XS2024-08-05
05056387439587Tinkham Sling Superfine Plus SmallM921537-S2024-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810045517582HandicareHANDICARE USA, INC.INE2025-08-13
00810045517599HandicareHANDICARE USA, INC.INE2025-08-13
00810045517605HandicareHANDICARE USA, INC.INE2025-08-13
00810045517575HandicareHANDICARE USA, INC.INE2025-05-09
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
00810045517490HandicareHANDICARE USA, INC.INE2024-10-11
00810045517506HandicareHANDICARE USA, INC.INE2024-10-11
00810045517513HandicareHANDICARE USA, INC.INE2024-10-11
00810045517520HandicareHANDICARE USA, INC.INE2024-10-11
00810045517483HandicareHANDICARE USA, INC.INE2024-09-24
07898493080073Skin Cooler Roller - LARGE (white)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080080Skin Cooler Roller - LARGE (lilac)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080097Skin Cooler Roller - LARGE (blue)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080103Skin Cooler Roller - LARGE (green)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080141Skin Cooler Roller - SMALL (green)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
00810045511481HandicareHANDICARE USA, INC.INE2020-09-16
00810045514765HandicareHANDICARE USA, INC.INE2020-09-09
00810045514796HandicareHANDICARE USA, INC.INE2020-09-09
00810045510002HandicareHANDICARE USA, INC.INE2020-08-26
00810045510071HandicareHANDICARE USA, INC.INE2020-08-26
00810045512365HandicareHANDICARE USA, INC.INE2020-08-26
00810045512464HandicareHANDICARE USA, INC.INE2020-08-26
00810045512778HandicareHANDICARE USA, INC.INE2020-08-26
00810045512792HandicareHANDICARE USA, INC.INE2020-08-26
00810045512815HandicareHANDICARE USA, INC.INE2020-08-26
00810045512839HandicareHANDICARE USA, INC.INE2020-08-26
00810045512860HandicareHANDICARE USA, INC.INE2020-08-26
00810045513034HandicareHANDICARE USA, INC.INE2020-08-26