FDA.reportPublic FDA data

CeroFrict

Primary DI
04897129990109
Brand
CeroFrict
Company
SML Med-Tech Solutions Limited
Model
SML007-TP01
Device description
Disposable Endoscope Tip Protector
Published
2023-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897129990106PackageGS175In Commercial Distribution
24897129990103PackageGS14In Commercial Distribution
04897129990109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489712999010614897129990106
2489712999010324897129990103
04897129990109048971299901094897129990109

GMDN Terms#

Term, Definition table
TermDefinition
Instrument hygienic-transportation bagA non-sterile flexible plastic container intended to collect and contain an instrument(s) [e.g., an endoscope] following an invasive procedure, for hygienic transportation of the device to a reprocessing facility. It is typically a drawstring bag/wrap which may be designed to be laid flat on the procedure tray/trolley during the procedure and then closed to contain the device; it is not a drape/cover. This is a single-use device.

Regulatory Flags#

DUNS number
687239367
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897129990727CeroFrictSML005-BB032023-10-24
04897129990734CeroFrictSML005-BB042023-10-24
04897129990758CeroFrictSML005-BB052023-12-27
04897129990765CeroFrictSML005-BB062023-12-27
04897129990772CeroFrictSML011-PL022023-12-27
04897129990789CeroFrictSML004-PY062023-12-27
04897129990796CeroFrictSML004-PY072023-12-27
04897129990802CeroFrictSML004-PY082023-12-27
04897129990819CeroFrictSML004-PY092023-12-27
04897129990826CeroFrictSML004-PY102023-12-27
04897129990840CeroFrictSML007-TP032023-12-27
04897129990857CeroFrictSML007-TP042023-12-27
04897129990833CeroFrictSML004-PY112023-12-27
04897129990024CeroFrictSML003-FJ092023-05-05
04897129990048CeroFrictSML004-PY022023-05-05
04897129990055CeroFrictSML004-PY032023-05-05
04897129990062CeroFrictSML004-PY042023-05-05
04897129990079CeroFrictSML004-PY052023-05-05
04897129990086CeroFrictSML005-BB012023-05-05
04897129990116CeroFrictSML011-PL012023-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603218259CO2 AdapterYangzhou Fartley Medical Instrument Technology Co., LtdFFY2026-10-25
06936603235508CO2 AdapterYangzhou Fartley Medical Instrument Technology Co., LtdFFY2026-10-25
04897129991755CeroFrictSML Med-Tech Solutions LimitedFFY2026-10-13
00724995356699CLEANASCOPESTERIS ITALY SRLFFY2026-05-26
00724995356705CLEANASCOPESTERIS ITALY SRLFFY2026-05-26
00724995356712CLEANASCOPE ADVANTAGESTERIS ITALY SRLFFY2026-05-26
00724995356729CLEANASCOPE ADVANTAGESTERIS ITALY SRLFFY2026-05-26
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957958andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106958016andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106958023andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957743andorate® Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-11-21
04547410564112FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
14547410564119FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
04897106957804Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957811Biopsy Port Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957828Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
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
04897106957071Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
14897106957078Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
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10850025860854CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
06009900408316PeditrolWISMED PL SP Z O OFFY2025-03-17