Gems
GEMS Patient Positioners Dark Gray EVA Foam Universal Fit Head Holder 1 per Each
4manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
| Klarity Medical & Equipment (GZ) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Beijing Health Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shenzhen Tengfei YU Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Tidi Products, LLC, United States |
|---|---|
| FDA product code | IWY |
| Device type | Holder, Head, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1920 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-21 |
| Record revised | 2023-03-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2023-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30911 | Withdrawn | |
| 31119 | Withdrawn | |
| 21787 | Withdrawn | |
| 30910 | Withdrawn | |
| 23531 | Withdrawn | |
| 31121 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Holder, Head, Radiographic | Domico Med-Device, LLC | 29 |
| Blessing Cathay | Blessing Cathay Corporation | 24 |
| Tidi | Tidi Products, LLC | 22 |
| Toshiba | Tidi Products, LLC | 9 |
| Scancoat | Domico Med-Device, LLC | 7 |
| Head-Positioning accessories | Baxter Medical Systems GmbH + Co. KG | 6 |
| GE Healthcare | Tidi Products, LLC | 6 |
| Neocis Guidance System | Neocis Inc | 5 |
| Neurologica | Tidi Products, LLC | 4 |
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 3 |
| X-Ray-Cassette-Handling | Baxter Medical Systems GmbH + Co. KG | 2 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 2 |
Showing 12 of 37. All products under Holder, Head, Radiographic
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.