Octane Straight IR
OCTANE STRAIGHT IR, Ti, 36X10X15, 6 DEG
6manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| K-MED Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 20 |
| Zhejiang Sorfa Life Science Research Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Xiamen Aquatown Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 5 |
Record
| Listed by | Choice Spine, LP |
|---|---|
| FDA product code | MPQ |
| Device type | Container, Specimen, Urine, Drugs Of Abuse, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3260 |
| 510(k) | K162103 |
| Record published | 2017-09-20 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Width 32 to 36 mm; length 10 mm; height 11 to 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PT23-36156 | Width 36 mm | In distribution |
| PT23-32116 | Length 10 mm | In distribution |
| PT23-36116 | Width 36 mm | In distribution |
| PT23-36126 | Width 36 mm | In distribution |
| PT23-32126 | Width 32 mm | In distribution |
| PT23-32136 | Length 10 mm | In distribution |
| PT23-32146 | Width 32 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ascend | Alphatec Spine, Inc. | 143 |
| Shark Lumbar Spacer System | Choice Spine, LP | 34 |
| Therapak | Therapak, LLC | 33 |
| Medline | Medline Industries, Inc. | 3 |
| Xpeedy | Cura Diagnostics Inc. | 3 |
| Mdhc | Mdhc Life Technologies (Kunshan) Co., Ltd. | 1 |
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.