FDA.reportPublic FDA data

V-Cide

Primary DI
H816VC3380
Brand
V-Cide
Company
CERTOL INTERNATIONAL, LLC
Model
VC338
Catalog number
VC338-1
Device description
Formaldehyde Device Sterilant
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
MEDSterilant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970726000VAPOCIDECottrell, Ltd.1998-05-18MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H816VC3381PackageHIBCC16In Commercial Distribution
H816VC3380PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Formaldehyde device sterilantA liquid substance that includes formaldehyde as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
095153714
Device count
1
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
H816PM75131ProView plusPM7513PM7513-12016-09-23
H816PNS1001ProTectorPNS100PNS100-12016-09-23
H816PIT1201ProChek IDPIT120PIT120-12016-09-23
H816PIT3401ProChek IDPIT340PIT340-12017-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056030400148Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
05056030400155Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
25056030404089Anterior CannulaSTERIMEDIX LIMITEDMED2026-02-24
10705037048755AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041480CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041510CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041596CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041602CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041664CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
20705037048752AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10885862658159EXACTECHExactech, Inc.MED2025-11-14
10885862658166EXACTECHExactech, Inc.MED2025-11-14
10885862658173EXACTECHExactech, Inc.MED2025-11-14
10885862658180EXACTECHExactech, Inc.MED2025-11-14
10885862658197EXACTECHExactech, Inc.MED2025-11-14
10885862658203EXACTECHExactech, Inc.MED2025-11-14
10885862658210EXACTECHExactech, Inc.MED2025-11-14
10885862658227EXACTECHExactech, Inc.MED2025-11-14
10885862658234EXACTECHExactech, Inc.MED2025-11-14
65056030402922Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-10-27
35056030400842Anterior Chamber Maintenance CannulaeSTERIMEDIX LIMITEDMED2025-10-10
45056030400139Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2025-10-06
00857635006040Aldahol 1.8ALDEN MEDICAL LLCMED2025-09-12
15056030401807Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-08-22
45056030400122Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2025-08-22
25056030401804Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-08-22
15056030401012Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
15056030401487Vitreoretinal HandpiecesSTERIMEDIX LIMITEDMED2025-03-25
25056030401316Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
15056030400961Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2025-02-17