FDA.reportPublic FDA data

CeroFrict

Primary DI
04897129991366
Brand
CeroFrict
Company
SML Med-Tech Solutions Limited
Model
SML004-PY02-LC
Device description
Disposable Polyp Trap
Published
2025-08-11
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
CBCBottle, Collection And Trap, Breathing System (Uncalibrated)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBCBottle, Collection And Trap, Breathing System (Uncalibrated)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897129991363PackageGS140In Commercial Distribution
24897129991360PackageGS14In Commercial Distribution
04897129991366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489712999136314897129991363
2489712999136024897129991360
04897129991366048971299913664897129991366

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. 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
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
04897129990499CeroFrictSML001-PT072023-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04897106956081andorate® ThomasTrap ™ Polyp Trap 2.0GA Health Company LimitedCBC2026-03-18
04897129991311CeroFrictSML Med-Tech Solutions LimitedCBC2025-08-11
34897129991312CeroFrictSML Med-Tech Solutions LimitedCBC2025-08-11
14897129991363CeroFrictSML Med-Tech Solutions LimitedCBC2025-08-11
04897129990789CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
04897129990796CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
04897129990802CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
04897129990819CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
04897129990826CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
14897129990786CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
14897129990793CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
14897129990809CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
14897129990816CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
14897129990823CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
04897129990833CeroFrictSML Med-Tech Solutions LimitedCBC2023-12-27
04897129990048CeroFrictSML Med-Tech Solutions LimitedCBC2023-05-05
04897129990055CeroFrictSML Med-Tech Solutions LimitedCBC2023-05-05
04897129990062CeroFrictSML Med-Tech Solutions LimitedCBC2023-05-05
04897129990079CeroFrictSML Med-Tech Solutions LimitedCBC2023-05-05
04897129990031CeroFrictSML Med-Tech Solutions LimitedCBC2023-05-05
14897129990045CeroFrictSML Med-Tech Solutions LimitedCBC2023-05-05
14897129990052CeroFrictSML Med-Tech Solutions LimitedCBC2023-05-05
14897129990069CeroFrictSML Med-Tech Solutions LimitedCBC2023-05-05
14897129990076CeroFrictSML Med-Tech Solutions LimitedCBC2023-05-05
04897106951482Polyp Trap with Two Removable Chambers (Non-sterile)GA Health Company LimitedCBC2022-04-11
14897106951489KEYSURGICAL® PolypTrap with 2 removable chambersGA Health Company LimitedCBC2022-04-11
00816734022849CaptureDIVERSATEK HEALTHCARE, INC.CBC2022-03-31
10816734022846CaptureDIVERSATEK HEALTHCARE, INC.CBC2022-03-31
04897106955060Four Chamber Polyp Trap (Non-sterile)GA Health Company LimitedCBC2022-03-25
04897106955091Single Chamber Polyp Trap (Non-sterile)GA Health Company LimitedCBC2022-03-25