FDA.report

Star

Primary DI
07320450170676
Brand
Star
Company
Etac Supply Center AB
Model
SC CUSTOM
Catalog number
ESSCCUSTOM
Published
2022-12-07
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
IMPCUSHION, WHEELCHAIR

Product Code Classifications

CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07320450170676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07320450170676073204501706767320450170676

GMDN Terms

TermDefinition
Air-filled chair cushionA static-air-inflated pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
354870610
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
07320451460288AltoUS802296032024-07-02
07320450001611Etac Supply Center ABHi-Loo803010672022-12-07
07320450001628Etac Supply Center ABHi-Loo803010652022-12-07
07320450001635Etac Supply Center ABHi-Loo803011012022-12-07
07320450001659Etac Supply Center ABHi-Loo803011052022-12-07
07320450002014Etac Supply Center ABTorkel803040012022-12-07
07320450002021Etac Supply Center ABLight804010012022-12-07
07320450002038Etac Supply Center ABLight804010032022-12-07
07320450002045Etac Supply Center ABLight804010052022-12-07
07320450002052Etac Supply Center ABLight804010072022-12-07
07320450002076Etac Supply Center ABLight804020022022-12-07
07320450002083Etac Supply Center ABLight804020042022-12-07
07320450002090Etac Supply Center ABLight804020062022-12-07
07320450002106Etac Supply Center ABLight804020072022-12-07
07320450002113Etac Supply Center ABRelieve804021012022-12-07
07320450002120Etac Supply Center ABRelieve804021022022-12-07
07320450002168Etac Supply Center ABFeed804031012022-12-07
07320450002175Etac Supply Center ABFeed804031022022-12-07
07320450002182Etac Supply Center ABFeed804031032022-12-07
07320450002199Etac Supply Center ABLight804032012022-12-07

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