FDA.reportPublic FDA data

PlastCare

Primary DI
D066PG30341
Brand
PlastCare
Company
Proguard Health, Inc
Model
PG-3034
Catalog number
PG-3034
Device description
"Cotton Rolls 1 1/2"" x 3/8"""
Published
2021-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
EFNCotton, Roll

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D066PG30342PackageHIBCC12In Commercial Distribution
D066PG30341PrimaryHIBCC0
D066PG30340Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cotton wool rollA device designed as an absorbent mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. This is a single-use device.

Regulatory Flags#

DUNS number
129529337
Device count
2000
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
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
D066PG44041PlastCarePG-4404PG-44042021-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194401657AiraAIRA, LLCEFN2026-01-16
00810194401794AiraAIRA, LLCEFN2026-01-16
00810124536909Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-12-05
50732224001086Ultra Gauze Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2025-10-23
00810124531843Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-09-03
00810132808203House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
10810132808200House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
00840456214947JMUJMU DENTAL, INCEFN2025-07-15
00840456214954JMUJMU DENTAL, INCEFN2025-07-15
00840456214961JMUJMU DENTAL, INCEFN2025-07-15
00840456214978JMUJMU DENTAL, INCEFN2025-07-15
00810132044281HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
20810132044285HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
00810132044274HCSConcordance Healthcare Solutions LLCEFN2025-03-05
20810132044278HCSConcordance Healthcare Solutions LLCEFN2025-03-05
D77810701991Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
D77810701992Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
10304040184803Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184810Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184827Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184858Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184865Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184806Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184813Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184820Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184851Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184868Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10850053289535SURGYCOSurgyco LLCEFN2024-08-09
10850053289542SURGYCOSurgyco LLCEFN2024-08-09
00850053289538SURGYCOSurgyco LLCEFN2024-08-09