FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040066307
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1000678
Catalog number
1000678
Device description
Film Holder Beige Angled
Published
2019-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
EGZHolder, film, x-ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040066307PrimaryGS10
00304040066300Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404006630710304040066307
00304040066300003040400663003040400663000304040066300

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, reusableA device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00FALSE

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
3
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
E24721301003290VistaPosition AnteriorDÜRR DENTAL SEEGZ2026-03-13
E24721301003300VistaPosition PosteriorDÜRR DENTAL SEEGZ2026-03-13
E24721301003320VistaPosition EndoDÜRR DENTAL SEEGZ2026-03-13
E24721301003330VistaPosition BitewingDÜRR DENTAL SEEGZ2026-03-13
00810126506092Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506184Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506818Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506825Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506801Visionary By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2025-12-16
00817169029335Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2025-12-16
00817169029861Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2025-12-16
00371347019636Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
08404535005134Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005226Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005257Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005288Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005349Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005011Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005042Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005073Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005103Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005165Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005196Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005318Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005370Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
07898561549150Cartridge (box) containing one pot with Digital Sensor Cone PositionerMaquira Industria de Produtos Odontologicos S/AEGZ2025-09-05
00304040192115CarinaHENRY SCHEIN, INC.EGZ2025-05-13
00304040190630Henry ScheinHENRY SCHEIN, INC.EGZ2025-03-05
D00361765100XiosDentsply International Inc.EGZ2024-11-06
D00361765280XiosDentsply International Inc.EGZ2024-11-06