Black Eye
Catalogue number TS-205, listed by THE Standard Co., Ltd., South Korea, under Marker, Colon. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | THE Standard Co., Ltd., South Korea |
|---|---|
| FDA product code | NBG |
| Device type | Marker, Colon |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-18 |
| Record revised | 2024-09-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton box of 12, canister of 12, canister of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS-205 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EndoINK(TM) Endoscopic Marker | Micro-Tech (Nanjing) Co., Ltd. | 4 |
| Blue Beacon(TM) GI Marker | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 2 |
| STA-BIL(TM) Non-migrating Endoscopic Ink | Micro-Tech (Nanjing) Co., Ltd. | 1 |
| Pointer Endoscopic Marker | Osteonic Co., Ltd. | 1 |
| Spot Ex Endoscopic Tattoo | GI Supply | 1 |
| Spot Endosopic Marker | GI Supply | 1 |
| Marker, Colon | Us Endoscopy | 1 |
| VueBlu | Cosmo Technologies Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.