FDA.reportPublic FDA data

PlastCare

Primary DI
D066PGSTA003B1
Brand
PlastCare
Company
Proguard Health, Inc
Model
PG-STA-003-B
Catalog number
PG-STA-003-B
Device description
"Surgical Aspirator Tips Small Vented 1/16"" Diam (Blue)"
Published
2021-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
EHZEvacuator, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D066PGSTA003B2PackageHIBCC50In Commercial Distribution
D066PGSTA003B1PrimaryHIBCC0
D066PGSTA003B0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129529337
Device count
25
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D066PGMBK11PlastCarePG-MBK1PG-MBK12021-07-02
D066PGMBK21PlastCarePG-MBK2PG-MBK22021-07-02
D066PGMBK31PlastCarePG-MBK3PG-MBK32021-07-02
D066PGMBL11PlastCarePG-MBL1PG-MBL12021-07-02
D066PGMBL21PlastCarePG-MBL2PG-MBL22021-07-02
D066PGMBL31PlastCarePG-MBL3PG-MBL32021-07-02
D066PGMHL11HopePG-MHL1PG-MHL12021-07-02
D066PG30341PlastCarePG-3034PG-30342021-07-02
D066PG10161PlastCarePG-1016PG-10162021-07-02
D066PG12191PlastCarePG-1219PG-12192021-07-02
D066PG22041PlastCarePG-2204PG-22042021-07-02
D066PG23371PlastCarePG-2337PG-23372021-07-02
D066PG23501PlastCarePG-2350PG-23502021-07-02
D066PG23901PlastCarePG-2390PG-23902021-07-02
D066PG27101PlastCarePG-2710PG-27102021-07-02
D066PG33041PlastCarePG-3304PG-33042021-07-02
D066PG33121PlastCarePG-3312PG-33122021-07-02
D066PG35101PlastCarePG-3510PG-35102021-07-02
D066PG35651PlastCarePG-3565PG-35652021-07-02
D066PG43121PlastCarePG-4312PG-43122021-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00723896029848Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
10371347017790Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017806Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017813Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017820Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347018448Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-03-04
TQ26ST2553121Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553211Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553311Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553411Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553621Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553921Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
10080196553686MEDLINEMEDLINE INDUSTRIES, INC.EHZ2024-09-19
10889950144838Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144845Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144852Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144869Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144876Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144883Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10888277652941MedlineMEDLINE INDUSTRIES, INC.EHZ2024-01-24
D248B101051Saliva Ejector Tip (Gray) - Pack of 10HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101081Saliva Ejector Tip (Gray) - Pack of 3HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101120Serviceable Saliva EjectorHAGER WORLDWIDE, INC.EHZ2023-09-12
10889950140717HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
10889950140724HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
H668D6401141PearsonKeystone IndustriesEHZ2023-02-20
H668D6401151PearsonKeystone IndustriesEHZ2023-02-20
H668D6401211PearsonKeystone IndustriesEHZ2023-02-20