Primary Device ID | 08809260260191 |
NIH Device Record Key | 39069d52-f101-4816-b7cd-615636d204d3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MiroCam Capsule Endoscope System |
Version Model Number | MR2000 |
Company DUNS | 631065794 |
Company Name | IntroMedic Co., LTD. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08809260260191 [Primary] |
GS1 | 18809260260198 [Package] Package: Large bos [3 Units] Discontinued: 2018-02-12 Not in Commercial Distribution |
NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-02-06 |
Device Publish Date | 2018-02-12 |
08809260260498 | Package system(MC1600-B Capsule and MR2000 Receiver) |
08809260260320 | MC1600-B |
98809260260446 | Package system(MC1200-B capsule, MR2000 receiver) |
08809260260290 | MC1200-B |
08809260260269 | MC1000-B |
08809260260191 | MR2000 |
18809260260587 | MC1600-B |
18809260260570 | MC2000-B |
18809260260563 | MC1200-B |