Nucleotome
3.5 MM Kit with aspiration bottle
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Clarus Medical, LLC., United States |
|---|---|
| FDA product code | HSZ |
| Device type | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K844131 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature -20 to 60 °C; Handling environment humidity 10 to 100 % RH; Handling environment atmospheric pressure 60 to 98 KiloPascal |
| Sizes | Outer diameter 2 to 3.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 23535 | Outer Diameter 3.5 mm | 2 | In distribution |
| 22500 | Outer Diameter 2.0 mm | 2 | In distribution |
| 23500 | Outer Diameter 2.5 mm | 2 | In distribution |
| 11000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 161 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | Anspach Effort, The | 56 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | Synthes Gmbh | 46 |
| MicroAire® | Microaire Surgical Instruments LLC | 27 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | Exactech, Inc. | 16 |
| Corb® | Zimmer, Inc. | 13 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 4 |
| Curvtek Cartridge | Biomet Orthopedics | 3 |
| Remover | Hankil Tech Medical Co., Ltd. | 3 |
| Micro Potuitary Forceps | Hankil Tech Medical Co., Ltd. | 2 |
| Curvtek EYE Needle | Biomet Orthopedics | 2 |
| Powerpro | ConMed Corporation | 2 |
Showing 12 of 25. All products under Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
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.