FDA.reportPublic FDA data

Star

Primary DI
07320450172830
Brand
Star
Company
Etac Supply Center AB
Model
Starlock 30X30X7.5 cm
Catalog number
ESSL31111-1
Device description
11.75 x 11.75 x 3
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

Product Codes#

Code, Name table
CodeName
IMPCUSHION, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07320450172830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07320450172830073204501728307320450172830

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00016958061888JAY LITEPRO CUSHIONSUNRISE MEDICAL (US) LLCIMP2026-03-05
H933EZ161896Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IMP2026-02-26
40080196312277MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
09420051799745Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799752Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799769Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799776Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799783Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799790Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799820Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799837Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799844Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799738Spex LimitedSPEX LIMITEDIMP2025-12-05
09420051799806Spex LimitedSPEX LIMITEDIMP2025-12-05
09420051799813Spex LimitedSPEX LIMITEDIMP2025-12-05
08717261074016Vicair 4 ZV 18x18x3.25"Vicair B.V.IMP2025-12-03
00860014212307Matrix AIREZ Custom BackMatrix Seating USA, LLCIMP2025-11-19
00860014212314Matrix AIREZ Custom CushionMatrix Seating USA, LLCIMP2025-11-19
00860014212321Matrix Custom Seat CushionMatrix Seating USA, LLCIMP2025-11-19
00860010877449Ease CushionEase Seating SystemsIMP2025-09-05
00860010877456Ease CushionEase Seating SystemsIMP2025-09-05
00860010877463Ease CushionEase Seating SystemsIMP2025-09-05
00860010877470Ease CushionEase Seating SystemsIMP2025-09-05
00840117321915DMECare Solutions Ever-Soft Lumbar Support Cushion,18"Dynarex CorporationIMP2025-08-22
00840117321939DMECare Solutions Ever-Soft Lumbar Support Cushion, 20" Dynarex CorporationIMP2025-08-22
00840117321953DMECare Solutions Ever-Soft Lumbar Support Cushion, 22"Dynarex CorporationIMP2025-08-22
09420082600096Spex LimitedSPEX LIMITEDIMP2025-05-31
09420082600133Spex LimitedSPEX LIMITEDIMP2025-05-31
09420082600065Spex LimitedSPEX LIMITEDIMP2025-05-30
09420082600072Spex LimitedSPEX LIMITEDIMP2025-05-30