FDA.report

CLEANASCOPE

Primary DI
00724995356705
Brand
CLEANASCOPE
Company
CANTEL MEDICAL (ITALY) SRL
Model
Sterile Tray Liner System
Catalog number
4010165
Device description
The CLEANASCOPE Sterile Liner System consists of sterile red covers to be used as part of the CLEANASCOPE system that provides identification of Clean and Contaminated equipment.
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FFYAdaptor, bulbs, miscellaneous, for endoscope

Product Code Classifications

CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50724995356700PackageGS1550In Commercial Distribution
00724995356705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499535670050724995356700
00724995356705007249953567057249953567050724995356705

GMDN Terms

TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Contacts

PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
437222573
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00724995356699CLEANASCOPESterile Tray Liner System40101672026-05-26
00724995356712CLEANASCOPE ADVANTAGESterile Tray Liner System40101692026-05-26
00724995356729CLEANASCOPE ADVANTAGESterile Tray Liner System40101682026-05-26
18011517151283ENDODRYStorage and Drying Cabinet151282023-11-02
18011517151269ENDODRYStorage and Drying Cabinet151262023-05-15
18011517103466CLEANASCOPE AdvantageEndoscope Storage and Transportation Carts1034662022-09-30
18011517103473CLEANASCOPE AdvantageEndoscope Storage and Transportation Carts1034702022-09-30
18011517103633CLEANASCOPEEndoscope Storage and Transportation Carts1036302022-09-30
18011517134675CLEANASCOPE AdvantageEndoscope Storage and Transportation Carts1034672022-09-30
18011517135481STORASCOPEEndoscope Storage and Transportation Carts1035482022-09-30
38011517135805CLEANASCOPESterile Tray Liner System1035802022-09-30
38011517135850CLEANASCOPE AdvantageSterile Tray Liner System1035852022-09-30
18011517136310CLEANASCOPEEndoscope Storage and Transportation Carts1036312022-09-30
18011517136334CLEANASCOPEEndoscope Storage and Transportation Carts1036332022-09-30
18011517151207ENDODRYStorage and Drying Cabinet151202022-09-30
18011517151214ENDODRYStorage and Drying Cabinet151212022-09-30
18011517151221ENDODRYStorage and Drying Cabinet151222022-09-30
18011517151238ENDODRYStorage and Drying Cabinet151232022-09-30
18011517151245ENDODRYStorage and Drying Cabinet151242022-09-30
18011517151252ENDODRYStorage and Drying Cabinet151252022-09-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00724995356699CLEANASCOPECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356712CLEANASCOPE ADVANTAGECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356729CLEANASCOPE ADVANTAGECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
14547410564119FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
04897106957798Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957801Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957818Biopsy Port Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957825Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957078Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
10850025860854CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
16009900408313PeditrolWISMED PL SP Z O OFFY2025-03-17
06009900408330Smart BulbWISMED PL SP Z O OFFY2025-03-17
06009900408439Mini PillowWISMED PL SP Z O OFFY2025-03-17
04547410516258FUJIFILMFUJIFILM CORPORATIONFFY2024-12-30
04547410522143FUJIFILMFUJIFILM CORPORATIONFFY2024-12-30
04049197151641RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-10-16
04049197522496RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-10-16
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00690521011526NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
00690521011533NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
00690521020672NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
00690521020689NON-STERILE Biopsy Valve Covers Batrik Medical Manufacturing IncFFY2024-10-08
04049197461054RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197461061RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197522465RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197522472RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04049197522489RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFFY2024-09-20
04055207019443E-LINERichard Wolf GmbHFFY2024-08-07
00840306830082Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FFY2024-08-06