Omnitex C
Conical sheath Omnitex C - white - nitrile
38manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (8), Shanghai (7). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Yongqing Huaguan Dental Instruments Factory | Langfang | Hebei | Contract manufacturer | 9 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| A.R. Medicom Inc. (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Changzhou Shengjie Medical Product Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
Showing 12 of 38. All 38 manufacturers in China registered for Chair, Dental, Without Operative Unit
Record
| Listed by | Omnia Medical, United States |
|---|---|
| FDA product code | NRU |
| Device type | Chair, Dental, Without Operative Unit |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6250 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-20 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 30.Z0131.00 | 500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 31 |
| A-dec | A-dec, Inc. | 30 |
| Palmero Healthcare, LLC | Palmero Healthcare LLC | 25 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 19 |
| iSmile | Ismile Dental Products Inc. | 18 |
| Forest | Ls Enterprises, Inc. | 18 |
| Unipack | Unipack LLC | 16 |
| Midmark | Midmark Corporation | 13 |
| DCI Edge | DCI International, LLC | 10 |
| MTI | Tech Industries. Inc. | 9 |
| Defend | Young Innovations Inc. | 9 |
| Aseptico | Aseptico, Inc. | 9 |
Showing 12 of 60. All products under Chair, Dental, Without Operative Unit
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.