Alteon
Alteon Mono Revstm Trial Size 22X295
21manufacturers in China registered for this device type
107catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 21. All 21 manufacturers in China registered for Template
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Lumen/inner diameter 22 to 40 mm; depth 5 mm; angle 10 °; outer diameter 15 to 24 mm; length 295 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-031-40-0736 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-42-0736 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-00-0040 | SIZE 40 | In distribution |
| 01-031-40-0436 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-003-23-0810 | SIZE 8-10 | In distribution |
| 01-031-48-0328 | Lateral angle of the face with respect to base plane | In distribution |
| 01-031-40-0732 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-48-0636 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-48-0232 | Lateral angle of the face with respect to base plane | In distribution |
| 01-031-48-0436 | Lateral angle of the face with respect to base plane | In distribution |
| 01-031-48-0632 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-46-0332 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-40-0532 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-00-0144 | SIZE 44 | In distribution |
| 01-031-00-0862 | SIZE 62 | In distribution |
| 01-031-42-0532 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-40-0128 | Lumen/Inner Diameter 28 mm | In distribution |
| 01-031-46-0732 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-42-0436 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-011-22-2295 | Outer Diameter 22 mm | In distribution |
| 01-011-19-2295 | Outer Diameter 19 mm | In distribution |
| 01-031-40-0836 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-46-0228 | Depth 5 mm | In distribution |
| 01-030-95-0000 | In distribution | |
| 01-031-00-0348 | SIZE 48 | In distribution |
| 01-031-40-0632 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-00-0142 | SIZE 42 | In distribution |
| 01-031-48-0128 | Angle 10 ° | In distribution |
| 01-031-48-0840 | Angle 10 ° | In distribution |
| 01-031-00-0758 | SIZE 58 | In distribution |
| 01-031-00-0756 | SIZE 56 | In distribution |
| 01-031-42-0740 | Lumen/Inner Diameter 40 mm | In distribution |
| 01-031-40-0636 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-42-0836 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-42-0732 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-46-0232 | Depth 5 mm | In distribution |
| 01-011-24-2295 | Outer Diameter 24 mm | In distribution |
| 01-031-48-0732 | Angle 10 ° | In distribution |
| 01-031-46-0536 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-48-0832 | Angle 10 ° | In distribution |
| 01-011-15-2295 | Length 295 mm | In distribution |
| 01-031-48-0740 | Angle 10 ° | In distribution |
| 01-031-42-0432 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-48-0640 | Lateral angle of the face with respect to base plane | In distribution |
| 01-031-40-0536 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-40-0832 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-46-0640 | Depth 5 mm | In distribution |
| 01-031-46-0432 | Depth of lip compared to neutral liner | In distribution |
| 01-031-40-0740 | Lumen/Inner Diameter 40 mm | In distribution |
| 01-031-00-0246 | SIZE 46 | In distribution |
| 01-031-00-0868 | SIZE 68 | In distribution |
| 01-011-18-2295 | Length 295 mm | In distribution |
| 01-031-48-0532 | Lateral angle of the face with respect to base plane | In distribution |
| 01-031-00-0864 | SIZE 64 | In distribution |
| 01-031-00-0866 | SIZE 66 | In distribution |
| 01-031-42-0332 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-003-22-0810 | SIZE 8-10 | In distribution |
| 01-031-00-0760 | SIZE 60 | In distribution |
| 01-031-42-0536 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-46-0840 | Lumen/Inner Diameter 40 mm | In distribution |
| 01-031-46-0836 | Depth 5 mm | In distribution |
| 01-031-48-0836 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-46-0832 | Depth 5 mm | In distribution |
| 01-011-23-2295 | Outer Diameter 24 mm | In distribution |
| 01-031-40-0228 | Lumen/Inner Diameter 28 mm | In distribution |
| 01-031-42-0640 | Lumen/Inner Diameter 40 mm | In distribution |
| 01-031-46-0436 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-40-0328 | Lumen/Inner Diameter 28 mm | In distribution |
| 01-031-46-0022 | Depth 5 mm | In distribution |
| 01-031-46-0736 | Depth 5 mm | In distribution |
| 01-031-00-0552 | SIZE 52 | In distribution |
| 01-031-48-0332 | Lateral angle of the face with respect to base plane | In distribution |
| 01-031-46-0740 | Depth of lip compared to neutral liner | In distribution |
| 01-031-42-0636 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-46-0128 | Lumen/Inner Diameter 28 mm | In distribution |
| 01-031-42-0232 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-00-0654 | SIZE 54 | In distribution |
| 01-011-21-2295 | Outer Diameter 21 mm | In distribution |
| 01-031-40-0432 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-003-23-0104 | SIZE 1-4 | In distribution |
| 01-031-42-0840 | Lumen/Inner Diameter 40 mm | In distribution |
| 01-011-16-2295 | Outer Diameter 16 mm | In distribution |
| 01-031-46-0328 | Lumen/Inner Diameter 28 mm | In distribution |
| 01-011-17-2295 | Outer Diameter 17 mm | In distribution |
| 01-011-20-2295 | Outer Diameter 20 mm | In distribution |
| 01-031-40-0332 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-42-0832 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-40-0840 | Lumen/Inner Diameter 40 mm | In distribution |
| 01-031-48-0736 | Lateral angle of the face with respect to base plane | In distribution |
| 01-031-42-0128 | Lumen/Inner Diameter 28 mm | In distribution |
| 01-031-46-0636 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-46-0632 | Depth 5 mm | In distribution |
| 01-031-42-0632 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-003-23-0507 | SIZE 5-7 | In distribution |
| 01-031-40-0232 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-42-0328 | Lumen/Inner Diameter 28 mm | In distribution |
| 01-031-40-0022 | Lumen/Inner Diameter 22 mm | In distribution |
| 01-031-48-0432 | Lumen/Inner Diameter 32 mm | In distribution |
| 01-031-42-0228 | Lumen/Inner Diameter 28 mm | In distribution |
| 01-031-00-0450 | SIZE 50 | In distribution |
| 01-003-22-0507 | SIZE 5-7 | In distribution |
| 01-003-22-0104 | SIZE 1-4 | In distribution |
| 01-031-46-0532 | Depth of lip compared to neutral liner | In distribution |
| 01-003-22-1117 | SIZE 11-17 | In distribution |
| 01-031-48-0536 | Lumen/Inner Diameter 36 mm | In distribution |
| 01-031-40-0640 | Lumen/Inner Diameter 40 mm | In distribution |
| 01-003-23-1117 | SIZE 11-17 | In distribution |
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Showing 12 of 2,940. All products under Template
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.