FDA.report

Plasdent

Primary DI
D832BE002S2
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
BE-002S
Catalog number
BE-002S
Device description
Soft Barrier Envelopes, Easy-Tear, For Phosphor Plates, #2
Published
2022-03-22
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
EGZHolder, Film, X-Ray
PEMDental Barriers And Sleeves

Product Code Classifications

CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D832BE002S2PackageHIBCC100In Commercial Distribution
D832BE002S1PrimaryHIBCC0
D832BE002S0Unit of UseHIBCC0

GMDN Terms

TermDefinition
X-ray film cassette, manualA device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. It is typically designed for use with a particular imaging system or image formatting unit and consists of a plastic or metal housing with removable metal or plastic inserts. Some film cassettes used in x-ray applications can incorporate an x-ray grid into the cassette design.

Sterilization Methods

Method

Regulatory Flags

DUNS number
190377184
Device count
100
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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D832600BF4000MAXAPPLICATOR II600B-F-400600B-F-4002025-08-01
D832600BR4000MAXAPPLICATOR II600B-R-400600B-R-4002025-08-01
D832600BSF4000MAXAPPLICATOR II600B-SF-400600B-SF-4002025-08-01
D83230000EXPANDII FLOSSII300030002025-06-02
D8323000B0EXPANDII FLOSSII3000B3000B2025-06-02
D8323000T0EXPANDII FLOSSII3000T3000T2025-06-02
D83231000FINE FLOSSII310031002025-06-02
D8323100B0FINE FLOSSII3100B3100B2025-06-02
D8323100T0FINE FLOSSII3100T3100T2025-06-02
D832CTRS20000PlasdentCTR-S2000CTR-S20002024-11-12
D832CTRS5400PlasdentCTR-S540CTR-S5402024-11-12
D8329000HVEXT0Plasdent 9000HV-EXT9000HV-EXT2024-09-06
D8329000PLG0Plasdent 9000PLG9000PLG2024-09-06
D832CCIMP20PlasdentCC-IMP2CC-IMP22024-09-06
D832TSTSA0ACUTIPS TST-SATST-SA2024-08-27
D832IITBIENAIR0PlasdentIIT-BIENAIRIIT-BIENAIR2024-07-30
D832IITKAVOT0PlasdentIIT-KAVO-TIIT-KAVO-T2024-07-30
D832IITNSK0PlasdentIIT-NSKIIT-NSK2024-07-30
D832IITU10PlasdentITT-U1ITT-U12024-07-30

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E24721301003290VistaPosition AnteriorDÜRR DENTAL SEEGZ2026-03-13
E24721301003300VistaPosition PosteriorDÜRR DENTAL SEEGZ2026-03-13
E24721301003320VistaPosition EndoDÜRR DENTAL SEEGZ2026-03-13
E24721301003330VistaPosition BitewingDÜRR DENTAL SEEGZ2026-03-13
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00810126506818Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506825Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
B9764488101OptiClear SleevesMinitube ABPEM2026-02-13
B9764488081OptiClear SleevesMinitube ABPEM2026-02-13
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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
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