FDA.report

PureLife X-Ray Film

Primary DI
00312045030752
Brand
PureLife X-Ray Film
Company
FLOW X RAY CORPORATION
Model
1200501
Device description
PLD-54 Size 0 Single
Published
2020-07-01
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
true

Related Records

Product Codes

CodeName
IWZFilm, Radiographic

Product Code Classifications

CodeDeviceSpecialtyClass
IWZFilm, RadiographicRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812045030757PrimaryGS10
00312045030752Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812045030757008120450307578120450307570812045030757
00312045030752003120450307523120450307520312045030752

GMDN Terms

TermDefinition
Dental x-ray film, non-screenA non-screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. It 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
010016319
Device count
100
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00812045030931DV-54 CHILD PEDO PAK182352023-08-09
00812045030948DV-53 CHILD TWIN PEDO PAK182362023-08-09
00812045030955FV-58 ADULT VALUE PAK183102023-08-09
00812045030962FV-57 ADULT TWIN VALUE PAK184102023-08-09
00812045030979DV-58 ADULT FRESH PAK186002023-08-09
00812045030986DV-57 ADULT TWIN FRESH PAK186012023-08-09
00812045030993FV-58 ADULT FRESH PAK186202023-08-09
00812045031006FV-57 ADULT TWIN FRESH PAK186212023-08-09

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