Disposable Handle Light Covers
Catalogue number 32.U0021.00, listed by Omnia Medical, United States, under Chair, Dental, Without Operative Unit. 38 manufacturers in China are registered for this product code.
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 | 2023-06-28 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 32.U0021.00 | 100 | 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.