FDA.report

Wolf X-Ray

Primary DI
00843696119577
Brand
Wolf X-Ray
Company
FLOW X RAY CORPORATION
Model
10005
Device description
Intensifying Screen, Detail Speed, 10" X 12"
Published
2020-09-26
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
EAMScreen, Intensifying, Radiographic

Product Code Classifications

CodeDeviceSpecialtyClass
EAMScreen, Intensifying, RadiographicRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843696119577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843696119577008436961195778436961195770843696119577

GMDN Terms

TermDefinition
X-ray intensifying screenA device typically considered to be a component of an x-ray film cassette used in diagnostic x-ray applications. It is typically used in pairs with double side emulsion x-ray film. It consists of a backing material, e.g., cardboard, plastic or metal; a reflecting layer of material, e.g., titanium dioxide; an active layer of light-emitting phosphor, e.g., calcium tungstate, barium sulfate, or rare earth material; and a protective layer, typically a plastic coating used to reduce static electricity and allow cleaning. It is used to reduce the x-ray dose to the patient and to allow for shorter exposure times to reduce motion artefact on exposed film.

Sterilization Methods

Method

Regulatory Flags

DUNS number
010016319
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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