FDA.reportPublic FDA data

CeroFrict

Primary DI
14897129990052
Brand
CeroFrict
Company
SML Med-Tech Solutions Limited
Model
SML004-PY03
Device description
Disposable Polyp Trap
Published
2023-05-05
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

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
14897129990052PackageGS140In Commercial Distribution
24897129990059PackageGS14In Commercial Distribution
04897129990055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489712999005214897129990052
2489712999005924897129990059
04897129990055048971299900554897129990055

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.

Sterilization Methods#

Method table
Method

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
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
04897106956081andorate® ThomasTrap ™ Polyp Trap 2.0GA Health Company LimitedCBC2026-03-18
04897129991311CeroFrictSML Med-Tech Solutions LimitedCBC2025-08-11
04897129991366CeroFrictSML 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
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