Soothe-Guard®
Soothe-Guard® Adult Apron with Collar .35mm - Royal Blue
6manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Ekong Technology Co., Limited | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EAJ |
| Device type | Apron, Leaded |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Storage | Special storage condition: Models with magnetic closure may have potential magnetic interference with pacemakers, defibrillators, and other active; Special storage condition: Hang or store flat |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 662205000 | In distribution | |
| 671804902 | In distribution | |
| 661804902 | In distribution | |
| 662204700 | In distribution | |
| 661905300 | In distribution | |
| 662005300 | In distribution | |
| 661904700 | In distribution | |
| 662305000 | In distribution | |
| 661904902 | In distribution | |
| 662305300 | In distribution | |
| 661805300 | In distribution | |
| 662104902 | In distribution | |
| 662104700 | In distribution | |
| 662204902 | In distribution | |
| 661804700 | In distribution | |
| 662105300 | In distribution | |
| 662205300 | In distribution | |
| 662105000 | In distribution | |
| 661905000 | In distribution | |
| 662304902 | In distribution | |
| 661805000 | In distribution | |
| 662004902 | In distribution | |
| 662005000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thyroid Shield | Burlington Medical, LLC | 1,161 |
| Wolf X-Ray | Flow X-Ray Corp. | 909 |
| ComfortLite | Aadco Medical, Inc. | 538 |
| Palmero Healthcare, LLC | Palmero Healthcare LLC | 402 |
| Euro | Burlington Medical, LLC | 390 |
| Rayshield | Aadco Medical, Inc. | 380 |
| 601 | Burlington Medical, LLC | 352 |
| F17 | Burlington Medical, LLC | 345 |
| Techno-Aide | Techno-Aide, Inc. | 327 |
| F111 | Burlington Medical, LLC | 322 |
| Skirt | Burlington Medical, LLC | 312 |
| A10 | Burlington Medical, LLC | 286 |
Showing 12 of 118. All products under Apron, Leaded
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.