Soothe-Guard AIR®
Soothe-Guard Air® Adult with Extended Collar .35mm - Charcoal
46manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (9), Hubei (9), Jiangsu (8). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
Showing 12 of 46. All 46 manufacturers in China registered for Apron, Protective
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | IWO |
| Device type | Apron, Protective |
| 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 | 2022-11-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Storage | Special storage condition: Models with magnetic closure have potential magnetic interference with pacemakers, defibrillators, and other active impl; Special storage condition: Hang or store flat |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 862105001 | In distribution | |
| 861805001 | In distribution | |
| 862305101 | In distribution | |
| 862104701 | In distribution | |
| 862105900 | In distribution | |
| 861905300 | In distribution | |
| 862005400 | In distribution | |
| 862005300 | In distribution | |
| 871805001 | In distribution | |
| 862304902 | In distribution | |
| 862105701 | In distribution | |
| 871805300 | In distribution | |
| 862005001 | In distribution | |
| 861804701 | In distribution | |
| 861804902 | In distribution | |
| 861805900 | In distribution | |
| 862205400 | In distribution | |
| 861805500 | In distribution | |
| 862104902 | In distribution | |
| 861905001 | In distribution | |
| 862306001 | In distribution | |
| 862106001 | In distribution | |
| 862105300 | In distribution | |
| 862305400 | In distribution | |
| 862305701 | In distribution | |
| 861904902 | In distribution | |
| 861905900 | In distribution | |
| 862305300 | In distribution | |
| 862205500 | In distribution | |
| 861905400 | In distribution | |
| 862205001 | In distribution | |
| 861805300 | In distribution | |
| 861904701 | In distribution | |
| 861904902 | In distribution | |
| 862204701 | In distribution | |
| 862005900 | In distribution | |
| 862305001 | In distribution | |
| 861905500 | In distribution | |
| 862105400 | In distribution | |
| 862205900 | In distribution | |
| 862305900 | In distribution | |
| 862004902 | In distribution | |
| 862205300 | In distribution | |
| 862204902 | In distribution | |
| 861805400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thyroid Shield | Burlington Medical, LLC | 1,932 |
| Wolf X-Ray | Flow X-Ray Corp. | 1,040 |
| Skirt | Burlington Medical, LLC | 678 |
| Euro | Burlington Medical, LLC | 407 |
| F111 | Burlington Medical, LLC | 385 |
| F112 | Burlington Medical, LLC | 348 |
| Pvest | Burlington Medical, LLC | 343 |
| Fvest | Burlington Medical, LLC | 342 |
| Vest | Burlington Medical, LLC | 337 |
| 601 | Burlington Medical, LLC | 330 |
| A10 | Burlington Medical, LLC | 329 |
| Thyroidshield | Burlington Medical, LLC | 311 |
Showing 12 of 236. All products under Apron, Protective
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.