FDA UDI
In Commercial Distribution
🇺🇸 United States
MiroCam Capusle Endoscope System
DI: 08809260260351
·
Model: MC2000-B
·
IntroMedic Co., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- MiroCam Capusle Endoscope System
- Primary DI
- 08809260260351
- Version / Model
- MC2000-B
- Company Name
- IntroMedic Co., LTD.
- Labeler DUNS
- 631065794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2018-02-12
- Public Version
- 5
- Public Version Date
- 2020-08-07
- Public Version Status
- Update
- Public Device Record Key
- 3946c1d4-edda-409c-a404-7f1b5cf28b59
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 38068 | Video capsule endoscopy system capsule | An electrically-powered, non-digestible capsule containing a video camera designed to pass through the gastrointestinal (GI) tract of a patient after being swallowed or endoscopically introduced, for the internal visualization and examination of the GI tract. It is intended to acquire video images of GI tract sections (e.g., oesophagus, small bowel and colon) and wirelessly transmit the images to a dedicated control unit/monitor (not included) via an external sensor array for examination and data recording. The capsule can be freely mobile or externally controlled by another device (not included); the capsule is excreted from the gut. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18809260260358 | GS1 | Large box | 16 | In Commercial Distribution | |
| Primary | 08809260260351 | GS1 | ||||
| Unit of Use | 08809260260153 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170438 | 000 |