FDA.reportPublic FDA data

Cetylcide-G

Primary DI
10631059012217
Brand
Cetylcide-G
Company
CETYLITE INDUSTRIES INC
Model
0122
Catalog number
0122
Device description
Disinfectant-Sterilant
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K974188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974188000CETYLCIDE-GKellerandheckman1998-09-10MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10631059012217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1063105901221710631059012217

GMDN Terms#

Term, Definition table
TermDefinition
Glutaraldehyde device sterilantA liquid substance that includes glutaraldehyde as its primary agent intended to completely destroy or eliminate (sterilize) all harmful microorganisms on a medical device (e.g., surgical or dental instrument); it may also be intended for use as a high-level disinfectant. The medical device is typically bathed by the substance for a specified period of time in order to achieve high-level disinfection or sterilization. This is a single-use device.

Regulatory Flags#

DUNS number
001283704
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10631059013016Power Cleaner013001302018-10-16
10631059080018Zarosen080008002016-09-16
10631059080117Varnal080108012016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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25056030403822Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403839Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
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25056030403853Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403860Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403877Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403884Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403891Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403907Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
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25056030403945Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403952Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
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10885862658210EXACTECHExactech, Inc.MED2025-11-14
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65056030402922Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-10-27
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