FDA UDI
In Commercial Distribution
🇺🇸 United States
MiroCam Capsule Endoscope System
DI: 08809260260375
·
Model: MC1000-B, MR1100
·
IntroMedic Co., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MiroCam Capsule Endoscope System
- Primary DI
- 08809260260375
- Version / Model
- MC1000-B, MR1100
- Company Name
- IntroMedic Co., LTD.
- Labeler DUNS
- 631065794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4e6ba327-cd6c-44c1-8cb5-c50eb9314528
Device Description
Package System(MC1000-B Capsule and MR1100 Receiver)
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 44836 | Video capsule endoscopy system | An assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient. The system typically consists of an operator workstation, various types of video capsules, an external sensor device that receives the wireless signals from the capsule, and a data recorder. As the capsule passes through the GI tract, video images of it sections (e.g., oesophagus, small bowel and colon) are relayed to the operator for examination and data recording; the capsule is egested from the gut. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 98809260260378 | GS1 | Large Box | 1 | In Commercial Distribution | |
| Primary | 08809260260375 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140751 | 000 |