FDA.reportPublic FDA data

PlastCare

Primary DI
D066PGSTRSS25101
Brand
PlastCare
Company
Proguard Health, Inc
Model
PG-STR-SS2510
Catalog number
PG-STR-SS2510
Device description
"Syringe Sleeves with Pre-Cut Opening (2-1/2"" x 10"")"
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
FRKChair, Examination And Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRKChair, Examination And TreatmentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D066PGSTRSS25102PackageHIBCC36In Commercial Distribution
D066PGSTRSS25101PrimaryHIBCC0
D066PGSTRSS25100Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental chair, electricA mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.

Regulatory Flags#

DUNS number
129529337
Device count
500
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
08500190351415Maxi S4000 Exam Chair, Power Base/Recline, Arms, Art HR, WhiteBoyd Industries, Inc.FRK2025-12-26
00728564010005Versa Exam TableThe Brewer Company LLCFRK2025-11-10
00728564015000Blood Drawing ChairThe Brewer Company LLCFRK2025-11-10
00728564020103Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564020301Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564020400Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021100Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021308Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021407Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022107Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022305Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022404Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564050001Access Exam TableThe Brewer Company LLCFRK2025-11-10
00728564050018Access Exam TableThe Brewer Company LLCFRK2025-11-10
00840456201015JMUJMU DENTAL, INCFRK2025-07-15
00840456201022JMUJMU DENTAL, INCFRK2025-07-15
00840456201039JMUJMU DENTAL, INCFRK2025-07-15
00840456201046JMUJMU DENTAL, INCFRK2025-07-15
00840456202906JMUJMU DENTAL, INCFRK2025-07-15
00840456202913JMUJMU DENTAL, INCFRK2025-07-15
00840456202920JMUJMU DENTAL, INCFRK2025-07-15
00840456202937JMUJMU DENTAL, INCFRK2025-07-15
00198506083952ELMED INCORPORATEDELMED INCORPORATEDFRK2025-07-11
06973134772133silverfoxSilverfox Corporation LimitedFRK2025-07-09
06973134774113silverfoxSilverfox Corporation LimitedFRK2025-07-09
D974BSI29111BritedentBright Supply, Inc.FRK2025-03-11
D974BSI29112BritedentBright Supply, Inc.FRK2025-03-11
00198506075179ELMED INCORPORATEDELMED INCORPORATEDFRK2025-02-17
00842180190122ELMEDELMED INCORPORATEDFRK2024-04-09
00842180147768ELMEDELMED INCORPORATEDFRK2024-03-06