FDA.reportPublic FDA data

CeroFrict

Primary DI
04897129990741
Brand
CeroFrict
Company
SML Med-Tech Solutions Limited
Model
SML007-TP02
Device description
Disposable Endoscope Tip Protector
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
14897129990748PackageGS175In Commercial Distribution
24897129990745PackageGS14In Commercial Distribution
04897129990741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489712999074814897129990748
2489712999074524897129990745
04897129990741048971299907414897129990741

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897129990550CeroFrictSML002-LP012023-04-17
04897129990642CeroFrictSML003-FJ012023-04-17
04897129991342CeroFrictSML011-PL01-BBP2025-08-12
14897129991349CeroFrictSML011-PL01-BBP2025-08-12
04897129991281CeroFrictSML005-BB072025-08-11
04897129991304CeroFrictSML005-BB092025-08-11
04897129991311CeroFrictSML004-PY01-CC2025-08-11
04897129991335CeroFrictSML011-PL01-B2025-08-11
04897129991359CeroFrictSML011-PL02-B2025-08-11
04897129991366CeroFrictSML004-PY02-LC2025-08-11
14897129991288CeroFrictSML005-BB072025-08-11
04897129991298CeroFrictSML005-BB082025-08-11
14897129991301CeroFrictSML005-BB092025-08-11
34897129991312CeroFrictSML004-PY01-CC2025-08-11
14897129991332CeroFrictSML011-PL01-B2025-08-11
14897129991356CeroFrictSML011-PL02-B2025-08-11
14897129991363CeroFrictSML004-PY02-LC2025-08-11
04897129990468CeroFrictSML001-PT042023-04-17
04897129990475CeroFrictSML001-PT052023-04-17
04897129990482CeroFrictSML001-PT062023-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995356699CLEANASCOPECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356705CLEANASCOPECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356712CLEANASCOPE ADVANTAGECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356729CLEANASCOPE ADVANTAGECANTEL MEDICAL (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
00850025860857CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
00850025860864CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
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
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