FDA.reportPublic FDA data

ProView Plus

Primary DI
H816PM35901
Brand
ProView Plus
Company
CERTOL INTERNATIONAL, LLC
Model
PM3590
Catalog number
PM3590-1
Device description
"Self-Sealing Sterilization Pouch/Packaging 3.5"" x 9"""
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953829000SAFE-T-SEALGs Medical Packaging, Inc.1995-11-09KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H816PM35902PackageHIBCC6In Commercial Distribution
H816PM35901PrimaryHIBCC0
H816PM35900Unit of UseHIBCC0

Regulatory Flags#

DUNS number
095153714
Device count
200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H816SM43401ProChek IDSM4340SM4340-12016-09-23
H816TSI4401ProChek STSI440TSI440-12016-09-23
H816QEZ21QEZQEZ2QEZ22023-06-02
H816QEZ22QEZQEZ2QEZ22023-06-02
H816BB0312H1BarrierBB-0312HBB-0312H-12017-01-13
H816BB0528X1BARRIERBB-0528XBB-0528X-12016-09-23
H816BB2930C1BarrierBB-2930CBB-2930C-12016-09-23
H816DC0115S1BarrierDC-0115SDC-0115S-12016-09-23
H816PFL0081ShieldPFL008PFL008-12016-09-23
H816PFLEL81ShieldPFLEL8PFLEL8-12016-09-23
H816PIT1001ProChek IDPIT100PIT100-12016-09-23
H816PM24401ProView plusPM2440PM2440-12016-09-23
H816PM27901ProView plusPM2790PM2790-12016-09-23
H816PM35541ProView plusPM3554PM3554-12016-09-23
H816PM54101ProView plusPM5410PM5410-12016-09-23
H816PM75131ProView plusPM7513PM7513-12016-09-23
H816PNS1001ProTectorPNS100PNS100-12016-09-23
H816VC3380V-CideVC338VC338-12016-09-23
H816PIT1201ProChek IDPIT120PIT120-12016-09-23
H816PIT3401ProChek IDPIT340PIT340-12017-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095488INSTRUSAFESummit Medical, Inc.KCT2026-11-05
00385640095471INSTRUSAFESummit Medical, Inc.KCT2026-11-04
10886982278746NASynthes GmbHKCT2026-11-03
10886982346421NASynthes GmbHKCT2026-11-03
00385640095433INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00841536147971ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147988ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148015ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148237ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148336ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148343ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148350ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148367ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147445ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147452ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147469ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147476ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147322ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147353ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147414ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148022ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148312ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148480ThompsonThompson Surgical Instruments, Inc.KCT2026-08-12
00841536148459ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536148466ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536147162ThompsonThompson Surgical Instruments, Inc.KCT2025-12-09
00841536146516ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146523ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146875ThompsonThompson Surgical Instruments, Inc.KCT2025-08-28
00841536146912ThompsonThompson Surgical Instruments, Inc.KCT2025-07-08