FDA.reportPublic FDA data

Steri-Shield

Primary DI
00850040097238
Brand
Steri-Shield
Company
Steri-Shield Products
Model
088-040
Device description
Anterior Bar - Case
Published
2022-06-03
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
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
10850040097235PrimaryGS10
00850040097238Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004009723510850040097235
00850040097238008500400972388500400972380850040097238

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
026709913
Device count
18
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
10850040097006Steri-Shield088-0152022-06-03
10850040097013Steri-Shield088-0222022-06-03
10850040097020Steri-Shield088-0582022-06-03
10850040097037Steri-Shield088-0892022-06-03
10850040097051Steri-Shield088-0652022-06-03
10850040097068Steri-Shield088-0662022-06-03
10850040097075Steri-Shield088-0722022-06-03
10850040097082Steri-Shield088-0752022-06-03
10850040097099Steri-Shield088-0882022-06-03
10850040097105Steri-Shield088-0242022-06-03
10850040097112Steri-Shield088-0262022-06-03
10850040097129Steri-Shield088-0342022-06-03
10850040097136Steri-Shield088-0322022-06-03
10850040097143Steri-Shield088-0302022-06-03
10850040097150Steri-Shield088-0282022-06-03
10850040097167Steri-Shield088-1242022-06-03
10850040097174Steri-Shield088-0232022-06-03
10850040097181Steri-Shield088-0252022-06-03
10850040097198Steri-Shield088-1382022-06-03
10850040097204Steri-Shield088-1362022-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10371347019633Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
10304040192112CarinaHENRY SCHEIN, INC.EGZ2025-05-13
D00361765101XiosDentsply International Inc.EGZ2024-11-06
D00361765281XiosDentsply International Inc.EGZ2024-11-06
D00361765361XiosDentsply International Inc.EGZ2024-11-06
D00361765511XiosDentsply International Inc.EGZ2024-11-06
D003B10730511UniversalDentsply International Inc.EGZ2024-11-06
D003B10730521UniversalDentsply International Inc.EGZ2024-11-06
D003B10730531UniversalDentsply International Inc.EGZ2024-11-06
D003B10730541UniversalDentsply International Inc.EGZ2024-11-06
08717228440007DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440014DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440021DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440113DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440120DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440137DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440144DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440168DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440175DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440182DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440212DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440250CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440281CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440298CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440366CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440373CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440380CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440397CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440403CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440410CeflaDuPhaMed B.V.EGZ2023-11-23