FDA UDI
In Commercial Distribution
🇺🇸 United States
NaviCam Capsule Endoscope System
DI: 00850015518201
·
Model: Controller/NaviEC-1000
·
ANX ROBOTICA CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NaviCam Capsule Endoscope System
- Primary DI
- 00850015518201
- Version / Model
- Controller/NaviEC-1000
- Catalog Number
- MC-US-1001
- Company Name
- ANX ROBOTICA CORP
- Labeler DUNS
- 024972857
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-08
- Public Version
- 2
- Public Version Date
- 2023-01-13
- Public Version Status
- Update
- Public Device Record Key
- 04736d55-086b-4b78-9ba5-b35e164aefc6
Device Description
Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator.
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QKZ | Magnetically Maneuvered Capsule Endoscopy System | Gastroenterology, Urology | 876.1310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65009 | Video capsule endoscopy system capsule magnetic manipulation unit | An electrically-powered, noninvasive device designed to control/manoeuvre a video capsule endoscopy system capsule (not included) in the gastrointestinal (GI) tract. It typically consists of a large magnetic device intended to magnetically couple with the capsule (e.g., a robotic arm with a magnet at its distal end, whole-body magnetic bore), patient table, and computer/console with dedicated software and controls; it is not a one-piece, hand-held device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850015518201 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN190037 | 000 |