Henry Schein
Maxi-Gard VL Barrier Envelope Size 0 100/Bx
40manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (10), Shanghai (8), Jiangsu (7). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Tianchang Jiarui Packaging Material Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Trelleborg Sealing Solutions Suzhou Company Limited | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Wenzhou Wapro Technology Co Ltd | Longgang | Zhejiang | Contract manufacturer | 1 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
Showing 12 of 40. All 40 manufacturers in China registered for Holder, Film, X-Ray
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EGZ |
| Device type | Holder, Film, X-Ray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.1905 |
| Premarket notification | Exempt |
| Record published | 2020-02-27 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: FALSE |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5701737 | 3 | In distribution | |
| 5701558 | 100 | In distribution | |
| 5701563 | 100 | In distribution | |
| 1024338 | 3 | In distribution | |
| 5701734 | 3 | In distribution | |
| 5700822 | 100 | In distribution | |
| 1000678 | 3 | In distribution | |
| 5701738 | 3 | In distribution | |
| 5701565 | 200 | In distribution | |
| 5704815 | In distribution | ||
| 5701733 | 5 | In distribution | |
| 5701566 | 200 | In distribution | |
| 5701735 | 3 | In distribution | |
| 5701559 | 100 | In distribution | |
| 5701561 | 100 | In distribution | |
| 5701736 | 3 | In distribution | |
| 5701564 | 300 | In distribution | |
| 5701567 | 200 | In distribution | |
| 5701560 | 300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrollByte | Directa AB | 181 |
| Rinn® | Dentsply LLC | 87 |
| Cefla | Duphamed B.V. | 24 |
| Techno-Aide | Techno-Aide, Inc. | 23 |
| DenBite | Duphamed B.V. | 20 |
| Steri-Shield | Steri-Shield Products, Inc. | 19 |
| Plasdent | Plasdent Corp. | 16 |
| Visionary by 3D Dental | 3D Dental Designs AND Development, LLC | 16 |
| Essentials by 3D Dental | 3D Dental Designs AND Development, LLC | 15 |
| Care Stream Dental | Duphamed B.V. | 14 |
| JMU | JMU Dental, Inc | 13 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 13 |
Showing 12 of 204. All products under Holder, Film, X-Ray
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K801079 | 1980-05-20 |
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.