FDA UDI
In Commercial Distribution
🇺🇸 United States
NaviCam Capsule Endoscope System
DI: 00850015518188
·
Model: Recorder/AKR-1
·
ANX ROBOTICA CORP
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NaviCam Capsule Endoscope System
- Primary DI
- 00850015518188
- Version / Model
- Recorder/AKR-1
- Catalog Number
- MC-US-1006
- 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
- eb60d6cb-e005-4a50-8300-d1a89f110002
Device Description
DATA RECORDER. 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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 64665 | Video capsule endoscopy monitoring kit | A collection of noninvasive devices intended to assist with the monitoring of image data from an ingested video capsule (not included), as it passes through the gastrointestinal (GI) tract. It typically consists of a monitor, an antenna that receives the wireless signals from the capsule, and additional devices utilized for the recording procedure (e.g., connection cables, holders, protectors); it may in addition include a capsule activator(s). This is a reusable device. | No | Active |
| 64666 | Video capsule endoscopy system monitor | An electrically-powered, portable component of a video capsule endoscopy system designed to be worn by a patient to continuously display and record photographic image data from an ingested video capsule (not included). It typically incorporates a display and controls and may include connection cables. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850015518188 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN190037 | 000 |