FDA.reportPublic FDA data

EndoCab

Primary DI
00816185001004
Brand
EndoCab
Company
Torvan Medical Inc
Model
4251SCSHG-16PTD2-TSBC
Catalog number
4251SCSHG-16PTD2-TSBC
Device description
ENDOCABINET, TOPLOAD, 16-SCOPE, 36x20x95, PURGE-TRACKING/BARCODE
Published
2024-05-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PUPEndoscope Maintenance System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUPEndoscope Maintenance SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816185001004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816185001004008161850010048161850010040816185001004

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope drying/storage cabinetAn electrically-powered enclosed chamber (the cabinet) designed to dry and store flexible endoscopes and their accessories in an environment that prevents bacterial growth. It uses high-efficiency particulate air (HEPA) inducted into the device and typically heated to 37ยบ Celsius so that the pre-sterilized endoscopes are dried both inside and out. They are then stored within the cabinet under conditions to prevent re-contamination (e.g., under ultraviolet (UV) light) so that they can be directly used without a need for disinfection. It is equipped with a door(s) and shelves to accommodate multiple endoscopes, and is electronically controlled to regulate the drying/storage processes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
200280404
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816185001165AquaBrush SystemT12-TAB-402766T12-TAB-4027662025-12-08
00816185001127Dovideq LeakControl DeviceT11-ASY-LEAKCONTROLT11-ASY-LEAKCONTROL2025-09-18
00816185000397EndoCab4362SCSHG-20PSD2-TSBC4362SCSHG-20PSD2-TSBC2024-05-10
00816185000403EndoCab4352SCSHG-16PSD2-TSBC4352SCSHG-16PSD2-TSBC2024-05-10
00816185000410EndoCab4342SCSHG-10PSD1-TSBC4342SCSHG-10PSD1-TSBC2024-05-10
00816185000427EndoCab4322SCSLG-6PSD1-TSBC4322SCSLG-6PSD1-TSBC2024-05-10
00816185000441EndoCab4362SCSHG-20PSD2-TSRF4362SCSHG-20PSD2-TSRF2024-05-10
00816185000458EndoCab4352SCSHG-16PSD2-TSRF4352SCSHG-16PSD2-TSRF2024-05-10
00816185000465EndoCab4342SCSHG-10PSD1-TSRF4342SCSHG-10PSD1-TSRF2024-05-10
00816185000472EndoCab4322SCSLG-6PSD1-TSRF4322SCSLG-6PSD1-TSRF2024-05-10
00816185000847EndoCab4261SCSHG-20PTD2-TSRF4261SCSHG-20PTD2-TSRF2024-05-10
00816185000854EndoCab4251SCSHG-16PTD2-TSRF4251SCSHG-16PTD2-TSRF2024-05-10
00816185000861EndoCab4241SCSHG-10PTD1-TSRF4241SCSHG-10PTD1-TSRF2024-05-10
00816185000915EndoCab4253SCSHG-5PTD1-TSRF4253SCSHG-5PTD1-TSRF2024-05-10
00816185000922EndoCab4253SCSHG-10PTD1-TSRF4253SCSHG-10PTD1-TSRF2024-05-10
00816185000991EndoCab4261SCSHG-20PTD2-TSBC4261SCSHG-20PTD2-TSBC2024-05-10
00816185001011EndoCab4241SCSHG-10PTD1-TSBC4241SCSHG-10PTD1-TSBC2024-05-10
00816185001066EndoCab4253SCSHG-5PTD1-TSBC4253SCSHG-5PTD1-TSBC2024-05-10
00816185001073EndoCab4253SCSHG-10PTD1-TSBC4253SCSHG-10PTD1-TSBC2024-05-10
00816185001141AutoSink with Endoscope Leak TesterT9-1B-3430HA-AST9-1B-3430HA-AS2025-04-28

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