FDA.reportPublic FDA data

Plasdent

Primary DI
D8327008111
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
7008-11
Catalog number
7008-11
Device description
Black Frame Face Visors, 1 Frame + 12 Visors
Published
2022-02-17
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
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8327008111PrimaryHIBCC0
D8327008110Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield setA two-piece device intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It consists of a reusable frame which clips around the forehead and multiple disposable (single-use) visors for attaching to the frame.

Regulatory Flags#

DUNS number
190377184
Device count
13
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D832CFT11PlasdentCFT-1CFT-12026-10-13
D832FT11PlasdentFT-1FT-12026-10-13
D832SAP21PlasdentSAP-2SAP-22026-10-13
D832SAP31PlasdentSAP-3SAP-32026-10-13
D832SAPR21PlasdentSAP-R2SAP-R22026-10-13
D832SAPR31PlasdentSAP-R3SAP-R32026-10-13
D832CT10L1PlasdentCT10-LCT10-L2026-10-12
D832CT10M1PlasdentCT10-MCT10-M2026-10-12
D832CT10S1PlasdentCT10-SCT10-S2026-10-12
D832CT10XL1PlasdentCT10-XLCT10-XL2026-10-12
D832CT2L1PlasdentCT2-LCT2-L2026-10-12
D832CT2M1PlasdentCT2-MCT2-M2026-10-12
D832CT2S1PlasdentCT2-SCT2-S2026-10-12
D832CT2XL1PlasdentCT2-XLCT2-XL2026-10-12
D832CT2XXL1PlasdentCT2-XXLCT2-XXL2026-10-12
D832CT6L1PlasdentCT6-LCT6-L2026-10-12
D832CT6M1PlasdentCT6-MCT6-M2026-10-12
D832CT6S1PlasdentCT6-SCT6-S2026-10-12
D832CT6XL1PlasdentCT6-XLCT6-XL2026-10-12
D832JK10L1PlasdentJK10-LJK10-L2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113242426BovieASPEN SURGICAL PRODUCTS, INC.HOY2026-08-17
00827989008137SAFEVIEWHealth Care Logistics, Inc.HOY2026-07-10
00860009651647KC Eye Tape - 50 PairsKelCor, LLCHOY2026-07-10
00840456222867JMUJMU DENTAL, INCHOY2026-07-07
00840456222874JMUJMU DENTAL, INCHOY2026-07-07
D125720C4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720CR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720T4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720TR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
D2481009320"""Heidi"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009330"""Ella"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009350"""Lucy"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
TQ26126151971Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.HOY2024-12-09
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
00194613017101MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613028190MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613002770MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-04-25
00630094055114Bioseal Inc.BIOSEALHOY2024-01-29
00630094055138Bioseal Inc.BIOSEALHOY2024-01-29
00630094055145Bioseal Inc.BIOSEALHOY2024-01-29
00630094055190Bioseal Inc.BIOSEALHOY2024-01-29
00630094404721Bioseal Inc.BIOSEALHOY2024-01-29
00630094540160Bioseal Inc.BIOSEALHOY2024-01-29
00630094540337Bioseal Inc.BIOSEALHOY2024-01-29
00630094540474Bioseal Inc.BIOSEALHOY2024-01-29
00630094551913Bioseal Inc.BIOSEALHOY2024-01-29