FDA UDI
In Commercial Distribution
🇺🇸 United States
Endocuff Vision
DI: 05060423410270
·
Model: ARV140U
·
BODDINGTONS PLASTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Endocuff Vision
- Primary DI
- 05060423410270
- Version / Model
- ARV140U
- Company Name
- BODDINGTONS PLASTICS LIMITED
- Labeler DUNS
- 216745893
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-23
- Public Version
- 3
- Public Version Date
- 2024-02-21
- Public Version Status
- Update
- Public Device Record Key
- f1da20c8-245d-4a2c-b3a8-7e0ea85e967c
Device Description
Olympus Size 4 Endocuff Vision Orange - Sterilised - 1 Pot
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60911 | Colonic endoscopy cuff | A sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy. It is in the form of a polymer cuff with retractable concentric fingers intended to open and grip the colon during pull back (exturbation) to straighten colonic folds and centralize the endoscope within the lumen; it is not intended to hinder intubation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060423410355 | GS1 | Shipper | 120 | In Commercial Distribution | |
| Package | 05060423410317 | GS1 | Display Carton | 8 | In Commercial Distribution | |
| Primary | 05060423410270 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 12.1 | Millimeter |