FDA.reportPublic FDA data

Steri-Shield

Primary DI
10850040097112
Brand
Steri-Shield
Company
Steri-Shield Products
Model
088-026
Device description
"Wingers-H ""Classic"" - SM, Case"
Published
2022-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10850040097112PrimaryGS10
00850040097115Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004009711210850040097112
00850040097115008500400971158500400971150850040097115

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, single-useA device designed to stabilize a dental x-ray film intraorally during the taking of a dental x-ray. It is typically an adhesive-backed device designed to fold into a T-shape which adheres to the x-ray film and provides a tab that, when bitten down on, stabilizes the film adjacent to the teeth whilst the x-ray is being taken. This is a single-use device.

Regulatory Flags#

DUNS number
026709913
Device count
24
Premarket exempt
true
Lot or batch
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
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
10850040097211Steri-Shield088-0442022-06-03

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
D003B10730551UniversalDentsply 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