Aligned Medical Solutions
U of A Main Dental Surgical Pack
7manufacturers in China registered for this device type
25catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
Record
| Listed by | Aligned Medical Solutions |
|---|---|
| FDA product code | OFX |
| Device type | General Purpose Dental Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Premarket notification | Exempt |
| Record published | 2018-11-14 |
| Record revised | 2019-05-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 10, case of 8, case of 6, case of 12, case of 20, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CPA25145 | In distribution | |
| VPP1014B | In distribution | |
| VPP1020 | In distribution | |
| AMS5971 | In distribution | |
| AMS4814A | In distribution | |
| VMSTSPLITPACK | In distribution | |
| VPP1020A | In distribution | |
| CPA26404 | In distribution | |
| VPP1020B | In distribution | |
| VPP1014A | In distribution | |
| PSS1788B | In distribution | |
| PSS2457C | In distribution | |
| VMEXPACK | In distribution | |
| AMS15374 | In distribution | |
| VMBASICIMPACKA | In distribution | |
| VMBASICIMPACK | In distribution | |
| VPP1016 | In distribution | |
| AMS17445 | In distribution | |
| 0057832 | In distribution | |
| AMS9538 | In distribution | |
| VMIMPACKA | In distribution | |
| AMS17524 | In distribution | |
| AMS14062 | In distribution | |
| VMIMPACKAA | In distribution | |
| PSS2457B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 813 |
| Medline Industries, Inc. | Medline Industries, Inc. | 287 |
| Stradis Healthcare | Stradis Healthcare | 69 |
| Stradis | Stradis Healthcare | 44 |
| ACS | American Contract Systems, Inc. | 25 |
| Centurion | Centurion Medical Products Corporation | 21 |
| Medical Action Industries | Medical Action Industries, Inc. | 10 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 4 |
| DeRoyal | Deroyal Industries, Inc. | 3 |
| Regard™ | ROi CPS LLC | 2 |
| Henry Schein | Henry Schein, Inc. | 2 |
Showing 12 of 46. All products under General Purpose Dental Tray
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.