FDA.reportPublic FDA data

ProView plus

Primary DI
H816PM75131
Brand
ProView plus
Company
CERTOL INTERNATIONAL, LLC
Model
PM7513
Catalog number
PM7513-1
Device description
"Self-Sealing Sterilization Pouch/Packaging 7.5"" x 13"""
Published
2016-09-23
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
H816PM75132PackageHIBCC6In Commercial Distribution
H816PM75131PrimaryHIBCC0
H816PM75130Unit 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
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
H816PM35901ProView PlusPM3590PM3590-12016-09-21
H816PM54101ProView plusPM5410PM5410-12016-09-23
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
00385640094795INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094801INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094818INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094825INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094726INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094733INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094740INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094757INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094764INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094771INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094788INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00724995238360V. MuellerSteris CorporationKCT2026-10-05
00385640094689INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094696INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094702INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094719INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094658INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094665INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094672INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094580INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094597INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094603INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094610INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094627INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094634INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094641INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00850092212009SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29
00860010729267STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729274STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729281SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29