FDA UDI
In Commercial Distribution
🇺🇸 United States
NaviCam Small Bowel Capsule Endoscopy System
DI: 06921010800531
·
Model: Locator/AKS-1
·
ANKON Technologies Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NaviCam Small Bowel Capsule Endoscopy System
- Primary DI
- 06921010800531
- Version / Model
- Locator/AKS-1
- Catalog Number
- SB-US-2006
- Company Name
- ANKON Technologies Co.,Ltd.
- Labeler DUNS
- 549329633
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-27
- Public Version
- 2
- Public Version Date
- 2024-01-01
- Public Version Status
- Update
- Public Device Record Key
- d1ae7db8-98c8-4608-82a4-d26054c8405b
Device Description
The Locator is a portable magnetic scanning device with built-in rechargeable lithium battery. It is used to turn the capsule on before it is swallowed by the patient and can be used for detecting whether a capsule is inside the human body and probing its approximate position.
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 |
|---|---|---|---|---|
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | Gastroenterology, Urology | 876.1300 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06921010800531 | GS1 |
Customer Contacts
- Phone
- +8613397176599
- [email protected]