FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoCab
DI: 00816185000571
·
Model: 4362SCAHG-20PSD2
·
Torvan Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndoCab
- Primary DI
- 00816185000571
- Version / Model
- 4362SCAHG-20PSD2
- Catalog Number
- 4362SCAHG-20PSD2
- Company Name
- Torvan Medical Inc
- Labeler DUNS
- 200280404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-10
- Public Version
- 1
- Public Version Date
- 2024-05-20
- Public Version Status
- New
- Public Device Record Key
- ea056ff1-f31f-49dc-87ad-0fb0aff13805
Device Description
ENDOCABINET, SIDELOAD, 20-SCOPE, ADD-ON, PURGE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUP | Endoscope Maintenance System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45635 | Endoscope drying/storage cabinet | An 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 37º 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816185000571 | GS1 |