Velcro Strap for Octopaque
Catalogue number ST-09, listed by Octostop, Inc., Canada, under Cradle, Patient, Radiologic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Octostop, Inc., Canada |
|---|---|
| FDA product code | KXH |
| Device type | Cradle, Patient, Radiologic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1830 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-11-16 |
| Record revised | 2019-05-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ST-09 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| pearltec | Pearl Inc. | 27 |
| ProFoam | Pearl Inc. | 22 |
| Moldcare RI II | Alcare Co., Ltd. | 11 |
| Moldcare | IZI Medical Products LLC | 6 |
| AccuBoost | Advanced Radiation Therapy, LLC | 5 |
| PearlFit | Pearl Inc. | 3 |
| ProBelt | Pearl Inc. | 2 |
| ProFoam Wedge 18x23x10 30° | Pearl Inc. | 1 |
| ProBelt 50 VH | Pearl Inc. | 1 |
| PearlFit Inlay Head | Pearl Inc. | 1 |
| ProBelt 350 Wrap | Pearl Inc. | 1 |
| Small U Head Cushions | Octostop, Inc. | 1 |
Showing 12 of 137. All products under Cradle, Patient, Radiologic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K953246 | 1995-09-29 |
| K930124 | 1994-02-09 |
| K930357 | 1993-07-13 |
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.