FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoRings
DI: 07290016767032
·
Model: E103
·
ENDOAID LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- EndoRings
- Primary DI
- 07290016767032
- Version / Model
- E103
- Company Name
- ENDOAID LTD
- Labeler DUNS
- 600318101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 799ad9c4-3359-45b6-b89b-6d599732b14d
Device Description
The EndoRings is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: Keeping the suitable depth of endoscope's view field.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 07290016767032 | GS1 | ||||
| Package | 17290016767039 | GS1 | White carton box | 15 | In Commercial Distribution | |
| Package | 27290016767036 | GS1 | Master box carton | 90 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 24 | Millimeter | |
| Device Size Text, specify | Ø50nn |