FDA.reportPublic FDA data

CeroFrict

Primary DI
04897129991335
Brand
CeroFrict
Company
SML Med-Tech Solutions Limited
Model
SML011-PL01-B
Device description
Disposable Protective Liner
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
PHTBasin For Endoscope Reprocessing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHTBasin For Endoscope ReprocessingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897129991332PackageGS175In Commercial Distribution
24897129991339PackageGS14In Commercial Distribution
04897129991335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489712999133214897129991332
2489712999133924897129991339
04897129991335048971299913354897129991335

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray cover, single-useA flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. 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
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
04897129990499CeroFrictSML001-PT072023-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183529239BR Surgical, LLCBR Surgical, LLCPHT2025-09-05
04897129991342CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-12
14897129991349CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-12
04897129991359CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
14897129991332CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
14897129991356CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
00840183528935BR Surgical, LLCBR Surgical, LLCPHT2024-11-07
00840183528676BR Surgical, LLCBR Surgical, LLCPHT2024-10-21
00840183528683BR Surgical, LLCBR Surgical, LLCPHT2024-10-21
00840183528690BR Surgical, LLCBR Surgical, LLCPHT2024-10-21
00841436113083GUSCIVCO MEDICAL INSTRUMENTS CO., INC.PHT2024-09-09
20841436113087GUSCIVCO MEDICAL INSTRUMENTS CO., INC.PHT2024-09-09
00840183527167BR Surgical, LLCBR Surgical, LLCPHT2024-07-16
00840183505516BR Surgical, LLCBR Surgical, LLCPHT2024-06-24
00840183520199BR Surgical, LLCBR Surgical, LLCPHT2024-06-24
00840183525699BR Surgical, LLCBR Surgical, LLCPHT2024-06-11
00840183500146BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500603BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500726BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500771BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500795BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183501334BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183501549BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183504113BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183504182BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183505110BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183506988BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183510114BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183511845BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183513115BR Surgical, LLCBR Surgical, LLCPHT2024-06-10