FDA UDI
In Commercial Distribution
🇺🇸 United States
Pathfinder® Endoscope Cap
DI: 00850006222032
·
Model: GI EC-0412-1
·
NEPTUNE MEDICAL INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pathfinder® Endoscope Cap
- Primary DI
- 00850006222032
- Version / Model
- GI EC-0412-1
- Catalog Number
- GI EC-0412-1
- Company Name
- NEPTUNE MEDICAL INC.
- Labeler DUNS
- 075588994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-02
- Public Version
- 1
- Public Version Date
- 2021-06-10
- Public Version Status
- New
- Public Device Record Key
- cc2f9ee0-937e-44ae-b37f-d68741feb67b
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
- No
- 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 |
|---|---|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64014 | Endoscope observation cap, single-use | A short, light-penetrating tube designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap and is available in a range of diameters to accommodate common endoscope diameters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850006222032 | GS1 |
Customer Contacts
- Phone
- 888-202-8401
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 12 | Millimeter | |
| Depth | 4 | Millimeter |