Bausch and Lomb
Head Neck Pack
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OGR |
| Device type | Ear, Nose, And Throat Surgical Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Premarket notification | Exempt |
| Record published | 2018-08-28 |
| Record revised | 2022-06-17 (version 3) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LYN0HDHNJHC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 16,169 |
| Medline Industries, Inc. | Medline Industries, Inc. | 8,277 |
| ACS | American Contract Systems, Inc. | 472 |
| Centurion | Centurion Medical Products Corporation | 124 |
| Regard™ | ROi CPS LLC | 76 |
| Aligned Medical Solutions | Aligned Medical Solutions | 75 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 33 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 22 |
| Stradis Healthcare | Stradis Healthcare | 15 |
| Integra® MicroFrance® | Integra LifeSciences Production Corporation | 14 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 14 |
| DeRoyal | Deroyal Industries, Inc. | 11 |
Showing 12 of 23. All products under Ear, Nose, And Throat Surgical 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.