Titan GEL IEP Stain (1 X 10 G Powder)
Catalogue number 3049, listed by Helena Laboratories, Corp., United States, under Support Gels. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Anhui (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 12 |
| Anhui Yixiang Trading Co., Ltd. | Hefei | Anhui | Repacker / relabeller | 13 |
| Foshan Pingchuang Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Tianjin Grand Paper Industry Co., Ltd. | Tianjin | Tianjin | Manufacturer | 2 |
Record
| Listed by | Helena Laboratories, Corp., United States |
|---|---|
| FDA product code | JZR |
| Device type | Support Gels |
| Device class | Class 1 |
| Regulation | 21 CFR 866.4900 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K831603 |
| Record published | 2017-03-17 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3049 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oasis | Trulife, Inc. | 54 |
| Oasis Elite | Trulife, Inc. | 42 |
| Elite | Trulife, Inc. | 21 |
| Azure | Trulife, Inc. | 17 |
| Senolo | Jiangsu Senolo Medical Technology Co., Ltd. | 3 |
| Alilite Contour PAD, Small 15.75 Inch Long | Alimed, LLC | 1 |
| Alilite Closed Head Ring Adolescent | Alimed, LLC | 1 |
| Alilite Supine Adolescent Head Rest | Alimed, LLC | 1 |
| Alilite Table PAD | Alimed, LLC | 1 |
| Alilite Lateral LEG | Alimed, LLC | 1 |
| Alilite Supine Head Rest | Alimed, LLC | 1 |
| Alilite Closed Head Ring Adult | Alimed, LLC | 1 |
Showing 12 of 34. All products under Support Gels
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K831603 | 1983-07-07 |
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.