FDA UDI
In Commercial Distribution
🇺🇸 United States
Pathfinder® Endoscope Overtube with Balloon
DI: 00850006222124
·
Model: GI 085140B-1
·
NEPTUNE MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pathfinder® Endoscope Overtube with Balloon
- Primary DI
- 00850006222124
- Version / Model
- GI 085140B-1
- Catalog Number
- GI 110140B-1
- Company Name
- NEPTUNE MEDICAL INC.
- Labeler DUNS
- 075588994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-20
- Public Version
- 1
- Public Version Date
- 2023-11-28
- Public Version Status
- New
- Public Device Record Key
- 8adb0e90-87ce-4585-af3f-05f35c556514
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 |
|---|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46687 | Endoscopic overtube, single-use | A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850006222124 | GS1 |
Customer Contacts
- Phone
- 8882028401
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230801 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 85 | Centimeter | |
| Catheter Working Length | 75 | Centimeter | |
| Outer Diameter | 14 | Millimeter |