FDA.report

Henry Schein

Primary DI
20304040040892
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1125306
Catalog number
1125306
Device description
DX-58 Vinyl Packet Size 2
Published
2019-04-03
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
20304040040892PackageGS150In Commercial Distribution
10304040040895PrimaryGS10
00304040040898Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404004089220304040040892
1030404004089510304040040895
00304040040898003040400408983040400408980304040040898

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00CSH uses Humidity Limitation, Protect from heat and radioactive sources, as well as Temperature Limit.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
150
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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00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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