FDA.report

Select Cassette with LANEX Medium Screens

Primary DI
60889971017697
Brand
Select Cassette with LANEX Medium Screens
Company
CARESTREAM HEALTH, INC.
Model
Select Cassette with LANEX Medium Screens
Catalog number
1017698
Device description
24X30CM KDK SLCT CASS W/LANX MED 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
60889971017697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
6088997101769760889971017697

GMDN Terms

TermDefinition
Dental x-ray film, screenA screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed to be sensitive primarily to the wavelengths of light emitted from an image intensifying screen. This x-ray film is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material.

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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