Holder, Head, Radiographic
AQUILION ONE HEAD HOLDER KIT. Includes: 9091 - HOLDER, AQUILION ONE CARBON FIBER (00810050241212), 9092 - PAD, AQUILION ONE ADULT HOLDER (00810050241380), 9093 - PAD, AQUILION ONE CHILD…
AQUILION ONE HEAD HOLDER KIT. Includes: 9091 – HOLDER, AQUILION ONE CARBON FIBER (00810050241212), 9092 – PAD, AQUILION ONE ADULT HOLDER (00810050241380), 9093 – PAD, AQUILION ONE CHILD HOLDER (00810050241397), 9094 – PAD, AQUILION ONE PEDIATRIC HOLDER (00810050242448), 9095 – PAD, AQUILION ONE WEDGE (00810050241403), 9096 – WEDGE, TAPER, 1.5” x 3.5” x 3” (10810050243008), 9097 – STRAP, VELTEX, 2” x 22” (10810050242896)
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 | Domico Med-Device, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2022-02-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Height 0.5 to 2.5 in; width 1.5 to 7 in; length 3 to 60 in; outer diameter 7 in |
| Distribution end date | 2023-02-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9411 | In distribution | ||
| 23804 | Height.75 in | In distribution | |
| CFI-866 | Outer Diameter 7 in | 20 | In distribution |
| 9014-B | In distribution | ||
| 164 | Outer Diameter 7 in | In distribution | |
| 2 | In distribution | ||
| 9408 | In distribution | ||
| 2-UF | In distribution | ||
| 9405 | In distribution | ||
| CFI-680 | Height 2.00 in | 20 | In distribution |
| 9025 | In distribution | ||
| 9403 | In distribution | ||
| 9095 | In distribution | ||
| 21574 | Height.75 in | In distribution | |
| 9090 | In distribution | ||
| 9091 | In distribution | ||
| 21578 | Width 2.00 in | In distribution | |
| 21577 | Height.50 in | In distribution | |
| 9404 | In distribution | ||
| 9007-A | Height.50 in | In distribution | |
| 9007 | In distribution | ||
| 9014-A | In distribution | ||
| 14 | In distribution | ||
| 9096 | Height 1.50 in | 2 | In distribution |
| 102 | In distribution | ||
| 9007-B | Width 2.00 in | In distribution | |
| 9014 | In distribution | ||
| 163 | Outer Diameter 7 in | Withdrawn | |
| 21576 | Height 1.13 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Blessing Cathay | Blessing Cathay Corporation | 24 |
| Tidi | Tidi Products, LLC | 22 |
| Toshiba | Tidi Products, LLC | 9 |
| Scancoat | Domico Med-Device, LLC | 7 |
| Gems | Tidi Products, LLC | 6 |
| 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.