FDA.reportPublic FDA data

TD-12®

Primary DI
B205CSTD121
Brand
TD-12®
Company
CS MEDICAL, LLC
Model
TD-12
Catalog number
CS-TD-12
Device description
PAA High-Level Disinfectant
Published
2020-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K192228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192228000CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC2020-04-01PSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B205CSTD121PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfectantA substance containing a chemical agent(s) intended to destroy harmful microorganisms or inhibit their activity on a medical device (e.g., surgical or dental instrument); it may also contain surfactants/cleaning agents or biological enzymes (e.g. protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period of time to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit; it is not supplied as an aerosol and does not include a wipe.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9192559472kendallashe@csmedicalllc.com

Regulatory Flags#

DUNS number
603864294
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B205CS2027901QwikCheck®202790CS-2027902023-07-31
B205CSECD1001Ethos®ECD-100CS-ECD-1002023-07-31
B205CSTD2001TD 200®TD 200CS-TD-2002020-04-15
B205CSTCD1000TEEClean®CS-TCD-1002019-09-25
B205TD100A0TD 100®TD 100CS-TD-1002016-09-16
B205TD100B0TD 100®TD 100CS-TD-1002016-11-11
B205CSAQ31AquaCide®AQ-3CS-AQ-32023-07-31
B205TD8A1TD-8®TD-8CS-TD-82016-11-11
B205TD5A1TD-5®TD-5CS-TD-52016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10705037041510CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041596CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
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10705037041664CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
20705037048752AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10885862658159EXACTECHExactech, Inc.MED2025-11-14
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10885862658197EXACTECHExactech, Inc.MED2025-11-14
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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