FDA.reportPublic FDA data

Stille

Primary DI
07332339220860
Brand
Stille
Company
Stille AB
Model
X-ray protective kit blue
Catalog number
535-1771
Device description
Curtain, protective, radiographic, consists of 4+2 lamellas in different size that is attached with velcro
Published
2020-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWQCurtain, Protective, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWQCurtain, Protective, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332339220860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332339220860073323392208607332339220860

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding curtainA flexible radiation protective device intended to shield the operator or other attending persons from unnecessary exposure to radiation emitted during a medical or dental procedure. The curtain is a flexible radiation blocking or attenuating barrier located between the individual and the source of primary or scattered radiation. This radiation barrier is designed to hang from rods or tracks attached to the ceiling, wall, radiation delivery equipment, or other radiation shields. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of flexible lead (Pb) or lead-equivalent material.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
355280827
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332339220587imagiQSide rail535-17202020-09-24
07332339220617imagiQSide rail535-17242020-09-24
07332339220655imagiQSide rail535-17282020-09-24
07332339220662imagiQFistula arm board535-17302020-09-24
07332339229559imagiQSide rail535-17232020-09-24
07332339232542MedstoneCatheter tray505-11312020-09-24
07332339221614ReisonLeg rest excluding clamp (1 pair)514-1004502022-04-04
07332339220594imagiQSide rail535-17212025-01-27
07332339220624imagiQSide rail535-17252025-01-27
07332339229566imagiQSide rail535-17292025-01-27
07332339242237imagiQPan Handle555-17602024-12-11
07332339242428imagiQPan Handle555-17612024-12-11
07332339242435imagiQCatheter tray 1000mm555-17502024-12-11
07332339242442imagiQCatheter tray 500mm555-17512024-12-11
07332339242459imagiQControl module555-17652024-12-11
07332339242466imagiQControl module555-17662024-12-11
07332339238179imagiQimagiQ3 Legacy550-17002024-11-04
07332339242473imagiQimagiQ3 Legacy550-17022024-11-04
07332339242480imagiQimagiQ3 Legacy550-17032024-11-04
07332339211769STILLE Various Instruments119-30010-15119-30010-152020-09-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850061871206IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
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00840348525861AADCOAADCO MEDICAL, INC.IWQ2022-12-19
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00840348525885AADCOAADCO MEDICAL, INC.IWQ2022-12-19