FDA.reportPublic FDA data

PlastCare

Primary DI
D066PG33121
Brand
PlastCare
Company
Proguard Health, Inc
Model
PG-3312
Catalog number
PG-3312
Device description
"Sterilization Pouches (3.25"" x 12"")"
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
FRGWrap, Sterilization
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D066PG33122PackageHIBCC10In Commercial Distribution
D066PG33121PrimaryHIBCC0
D066PG33120Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Regulatory Flags#

DUNS number
129529337
Device count
200
Lot or batch
true
Expiration date on label
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
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
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
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00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
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00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCJOJ2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05