Aligned Medical Solutions
Kenneth Press Oral Pack
2manufacturers in China registered for this device type
75catalogue numbers in this listing
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 | Aligned Medical Solutions |
|---|---|
| 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 | 2024-05-13 |
| Record revised | 2023-07-28 (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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 6, case of 10, case of 8, case of 3, case of 4, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMS11480 | In distribution | |
| AMS13188 | In distribution | |
| AMS10673B | In distribution | |
| AMS14065 | In distribution | |
| AMS14580A | In distribution | |
| AMS4417B | In distribution | |
| AMS143891 | In distribution | |
| AMS11542 | In distribution | |
| 009119-1 | In distribution | |
| AMS18301 | In distribution | |
| AMS7620A | In distribution | |
| AMS6148C | In distribution | |
| AMS12422A | In distribution | |
| AMS7107A | In distribution | |
| AMS14989 | In distribution | |
| AMS7124 | In distribution | |
| AMS16596 | In distribution | |
| AMS3628 | In distribution | |
| AMS14989C | In distribution | |
| AMS7107 | In distribution | |
| AMS2727 | In distribution | |
| AMS8322 | In distribution | |
| AMS7288 | In distribution | |
| AMS5913A | In distribution | |
| AMS17210 | In distribution | |
| AMS17230 | In distribution | |
| AMS3627 | In distribution | |
| AMS16242A | In distribution | |
| AMS19597 | In distribution | |
| AMS1873 | In distribution | |
| AMS10358 | In distribution | |
| AMS14064 | In distribution | |
| AMS16418 | In distribution | |
| AMS14063 | In distribution | |
| AMS14989A | In distribution | |
| AMS15863A | In distribution | |
| AMS14058 | In distribution | |
| AMS16242 | In distribution | |
| AMS14065A | In distribution | |
| AMS13680 | In distribution | |
| AMS6373 | In distribution | |
| AMS13870A | In distribution | |
| AMS12206 | In distribution | |
| AMS7886 | In distribution | |
| AMS6356 | In distribution | |
| AMS14391A | In distribution | |
| AMS18596 | In distribution | |
| AMS11480A | In distribution | |
| AMS13870 | In distribution | |
| AMS3237A | In distribution | |
| AMS15517 | In distribution | |
| AMS15742 | In distribution | |
| AMS4417 | In distribution | |
| AMS11983 | In distribution | |
| AMS7391 | In distribution | |
| AMS6148B | In distribution | |
| AMS17148 | In distribution | |
| 0091190 | In distribution | |
| AMS11983A | In distribution | |
| AMS17148A | In distribution | |
| AMS16101 | In distribution | |
| AMS11032B | In distribution | |
| AMS17729 | In distribution | |
| AMS4417A | In distribution | |
| AMS16955 | In distribution | |
| AMS16242B | In distribution | |
| AMS11032A | In distribution | |
| AMS17396 | In distribution | |
| AMS3951 | In distribution | |
| AMS6777 | In distribution | |
| AMS4417C | In distribution | |
| AMS4417D | In distribution | |
| AMS15863 | In distribution | |
| AMS4214 | In distribution | |
| AMS3231C | 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 |
| 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 |
| Invenio | GRI-Alleset, Inc. | 8 |
Showing 12 of 23. All products under Ear, Nose, And Throat Surgical Tray
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Windstone Medical Packaging, Inc. | UDI-DI | 2026-06-08 | Class II | Material/Component Contamination | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin le | 919 units |
| Windstone Medical Packaging, Inc. | UDI-DI | 2024-08-16 | Class II | Use error | Due to convenience kits containing a kit component that is under a recall action for improper use. | 60 packs |
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.