FDA.report

Select Cassette with LANEX Fast Screens

Primary DI
60889971005366
Brand
Select Cassette with LANEX Fast Screens
Company
CARESTREAM HEALTH, INC.
Model
Select Cassette with LANEX Fast Screens
Catalog number
1005362
Device description
30X40CM SLCT CASS W/LANX FST C1
Published
2016-09-16
Public version status
Update
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
IXACassette, radiographic film

Product Code Classifications

CodeDeviceSpecialtyClass
IXACassette, Radiographic FilmRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
60889971005366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
6088997100536660889971005366

GMDN Terms

TermDefinition
X-ray film cassette, automatic film changingA housing for x-ray film specifically designed to be used in, and work as part of, an automated x-ray film changing system. The housing is intended to be loaded with x-ray film under appropriate darkroom conditions, and is then inserted into the loading magazine of the film changing system. After exposure, it is held in a receiving magazine until the operator removes it for final processing.

Sterilization Methods

Method

Regulatory Flags

DUNS number
793169512
Device count
1
DM exempt
false
Premarket exempt
false
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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