FDA.report

High Easy Mesh Looped Hip Tapes LOOPS MEDIUM

Primary DI
05056387416342
Brand
High Easy Mesh Looped Hip Tapes LOOPS MEDIUM
Company
SILVALEA LIMITED
Model
M921513-M
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

Related Records

Product Codes

CodeName
INESling, Overhead Suspension, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05056387416342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05056387416342050563874163425056387416342

GMDN Terms

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

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

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05056387439457Rachel Harness Mesh Navy SmallM921535-S2024-08-05
05056387439464Rachel Harness Mesh Navy MediumM921535-M2024-08-05
05056387439471Rachel Harness Mesh Navy LargeM921535-L2024-08-05
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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
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