FDA.reportPublic FDA data

Perfect Sterilization

Primary DI
00850048332249
Brand
Perfect Sterilization
Company
Pristine Dental Supplies, Inc.
Model
PFS-3.5-6.5
Device description
"3.5X6.5"" Sterilization Pouches - SELF SEALING AND COLOR CHANGING 200 PER BOX 10 BOXES PER CASE"
Published
2023-03-18
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
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
00850048332249PrimaryGS10
00850048332072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048332249008500483322498500483322490850048332249
00850048332072008500483320728500483320720850048332072

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization container linerA non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.

Regulatory Flags#

DUNS number
080057154
Device count
200

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048332799Safety Max DiamondSMD-35-XS2023-03-30
00850048332836Safety Max DiamondSMD-35-M2023-03-30
00850048332867Safety Max DiamondSMD-35-L2023-03-30
00850048332898Safety Max DiamondSMD-35-XL2023-03-30
00850048332911Safety Max DiamondSMD-35-S2023-03-30
00850048332652Safety Max DiamondSMD-35-XS2023-03-30
00850048332829Safety Max DiamondSMD-35-M2023-03-30
00850048332850Safety Max DiamondSMD-35-L2023-03-30
00850048332881Safety Max DiamondSMD-35-XL2023-03-30
00850048332928Safety Max DiamondSMD-35-S2023-03-30
00850048332287Perfect SterilizationPFS-7.5-13 2023-03-18
00850048332294Safety Max DiamondLIF-59-XS2023-03-18
00850048332355Safety Max DiamondLCIF-63-M2023-03-18
00850048332362Safety Max DiamondLCIF-63-L2023-03-18
00850048332379SAFETY MAX GOLDSMN-45-XL2023-03-18
00850048332447SAFETY MAX GOLDSMN-45-M2023-03-18
00850048332454SAFETY MAX GOLDSMN-45-S2023-03-18
00850048332461SAFETY MAX GOLDSMN-45-XS2023-03-18
00850048332485SAFETY MAX GOLDSMN-45-L2023-03-18
00850048332522Perfect SterilizationPFS-2.75-10 2023-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D771603531Dental CityICP, INC.JOJ2026-05-27
D771604231Dental CityICP, INC.JOJ2026-05-27
D771604251Dental CityICP, INC.JOJ2026-05-27
D771604271Dental CityICP, INC.JOJ2026-05-27
D771604281Dental CityICP, INC.JOJ2026-05-27
D771604291Dental CityICP, INC.JOJ2026-05-27
D771604391Dental CityICP, INC.JOJ2026-05-27
08404535029437Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-13
08404535025927Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-01
08404535015003Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535019100Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025217Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025248Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025279Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
10197344140008MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140015MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140022MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149018MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149025MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149032MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10198459366277MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FRG2025-06-16
07798375772815VERISURE™TERRAGENE S.A.JOJ2025-06-03
07798375772853SEALSURE™TERRAGENE S.A.JOJ2025-06-03
07798375772730VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772747VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772792VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772624BIOTRACE™TERRAGENE S.A.JOJ2024-11-12
07798375772839VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772891VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772952VERISURE™TERRAGENE S.A.JOJ2024-11-12