FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040040984
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1125328
Catalog number
1125328
Device description
Duplicating Film
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

Product Codes#

Code, Name table
CodeName
IWZFilm, radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWZFilm, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040040984PackageGS110In Commercial Distribution
10304040040987PrimaryGS10
00304040040980Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404004098420304040040984
1030404004098710304040040987
00304040040980003040400409803040400409800304040040980

GMDN Terms#

Term, Definition table
TermDefinition
Medical x-ray film, non-screenA non-screen x-ray film specifically designed for use in medical imaging applications. Non-screen x-ray film 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#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
50
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810106411040Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411057Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411064Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411071Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411088Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411095Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411101Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411118Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
D678734701Plate Transfer BoxAIR TECHNIQUES, INC.IWZ2025-09-05
00810050855457Rad ControlTYPENEX MEDICAL LLCIWZ2025-05-23
00810050855471Rad ControlTYPENEX MEDICAL LLCIWZ2025-05-23
00810106410937Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2025-01-28
00810106410944Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2025-01-28
00810106410920Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-12-30
00810106410913Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-11-21
00810106410906Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-11-11
05060608881512Precision Cut GafChromic™ FilmSUN NUCLEAR CORP.IWZ2024-11-01
00810106410869Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410876Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410883Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410890Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410852Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-22
00810106410814Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-09-04
00810106410821Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-09-04
00810106410838Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-09-04
00810050855648Rad ControlTYPENEX MEDICAL LLCIWZ2024-07-15
00810106410791Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-06-04
00810106410760Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-05-17
00810106410777Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-05-17
00810106410784Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-05-17