FDA.report

FILM FSS-58 D ADULT SINGLE BUTTERFLY PACKETS F SPEED

Primary DI
00812045030481
Brand
FILM FSS-58 D ADULT SINGLE BUTTERFLY PACKETS F SPEED
Company
FLOW X RAY CORPORATION
Model
19620
Device description
FILM FSS-58 D ADULT SINGLE BUTTERFLY PACKETS F SPEED, FILM INTRAORAL X-RAY
Published
2020-02-28
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
00812045030481PrimaryGS10
00308120450300Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812045030481008120450304818120450304810812045030481
00308120450300003081204503003081204503000308120450300

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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00081204503900DV-58 ADULT ECONO PAK182042023-08-09
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00812045030634DX-42 BITE CHEX180602023-08-09
00812045030832DV-57 ADULT TWIN VALUE PAK18201E2023-08-09
00812045030849DV-53 CHILD TWIN PEDO PAK18236E2023-08-09
00812045030856DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET19235E2023-08-09
00812045030863DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET19601E2023-08-09
00812045030870 DUPLICATING FILM, 14 X 17"311762023-08-09
00812045030887DV-58 ADULT VALUE PAK182002023-08-09
00812045030894DV-57 ADULT TWIN VALUE PAK182012023-08-09
00812045030917DV-54 CHILD ECONO PAK182062023-08-09
00812045030924FV-58 ADULT ECONO PAK182152023-08-09
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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