Pearltec
Convenience Kit. Short-term patient positioning and stabilization device during invasive and noninvasive procedures to be used on intact patient's skin. Non-Sterile and not to be used in…
Convenience Kit. Short-term patient positioning and stabilization device during invasive and noninvasive procedures to be used on intact patient’s skin. Non-Sterile and not to be used in the sterile field.
2manufacturers in China registered for this device type
27catalogue numbers in this listing
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 | Pearl Inc., United States |
|---|---|
| FDA product code | KXH |
| Device type | Cradle, Patient, Radiologic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1830 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-13 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ProFoam Table Mat 200x60x3 DSGP | In distribution | |
| Positioning KIT IS Basic | In distribution | |
| ProFoam Plate 50x25x1 DSR | In distribution | |
| ProFoam Table Mat 200x60x5 MFGP | In distribution | |
| BabyFix XL | In distribution | |
| ProFoam Table Mat 200x70x3 DSGP | In distribution | |
| Positioning KIT DXR Basic | In distribution | |
| Neuro Kit | In distribution | |
| Sandbag 24×18, 1.25 kg | In distribution | |
| ProFoam Table Mat 200x60x3 DSG | In distribution | |
| ProBelt 200 U5 | In distribution | |
| ProFoam Table Mat 200x60x3 DSRG | In distribution | |
| ProFoam Table Mat 225x55x3 CLX | In distribution | |
| ProFoam Table Mat 200x70x3 DSRG | In distribution | |
| ProFoam Table Mat 200x70x3 DSRGP | In distribution | |
| ProFoam Table Mat 200x70x3 DSG | In distribution | |
| Positioning KIT IS Advanced | In distribution | |
| ProFoam Head | In distribution | |
| ProFoam Table Mat 200x60x5 MFG | In distribution | |
| ProFoam Head/Neck | In distribution | |
| ProFoam Plate 100x25x1 DSR | In distribution | |
| Positioning KIT HP Advanced | In distribution | |
| Sandbag 30×20, 2 kg | In distribution | |
| Positioning KIT DXR Advanced | In distribution | |
| ProBelt 350 U5 | In distribution | |
| ProFoam Table Mat 200x60x3 DSRGP | In distribution | |
| Sandbag 40×20, 3 kg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| FoamFit Plate 18x8x2 | Pearl Inc. | 1 |
Showing 12 of 137. All products under Cradle, Patient, Radiologic
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.