Clearcut
13 catalogue numbers from Diameter 16, listed by Teknimed SAS, France, under Cement Obturator. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Teknimed SAS, France |
|---|---|
| FDA product code | LZN |
| Device type | Cement Obturator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2015-10-16 |
| Record revised | 2020-11-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature up to 30 °C |
| Sizes | Outer diameter 6 to 18 mm |
| Distribution end date | 2019-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Diameter 16 | Outer Diameter 16 mm | In distribution |
| Diameter 10 | Outer Diameter 10 mm | In distribution |
| Diameter 18 | Outer Diameter 18 mm | In distribution |
| Diameter 14 | Outer Diameter 14 mm | In distribution |
| Diameter 08 | Outer Diameter 8 mm | In distribution |
| Diameter 12 | Outer Diameter 12 mm | In distribution |
| Diameter 06 | Outer Diameter 06 mm | In distribution |
| Diameter 12 | Outer Diameter 12 mm | Withdrawn |
| Diameter 16 | Outer Diameter 16 mm | Withdrawn |
| Diameter 14 | Outer Diameter 14 mm | Withdrawn |
| Diameter 10 | Outer Diameter 10 mm | Withdrawn |
| Diameter 18 | Outer Diameter 18 mm | Withdrawn |
| Diameter 08 | Outer Diameter 8 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exeter | Howmedica Osteonics Corp | 11 |
| Cement Obturator | Zimmer, Inc. | 10 |
| Buck | Smith & Nephew, Inc. | 8 |
| DJO Surgical | Encore Medical, L.P. | 6 |
| Spectron | Smith & Nephew, Inc. | 6 |
| Cemstop | Teknimed SAS | 6 |
| MectaPlug | Teknimed SAS | 6 |
| Biostop | Depuy Orthopaedics, Inc. | 5 |
| Bone Plug | Howmedica Osteonics Corp | 3 |
| ACM BioPrep | Stryker GmbH | 2 |
| Perfecta | Microport Orthopedics Inc. | 2 |
| Cement Restrictor | Tornier Inc. | 2 |
Showing 12 of 17. All products under Cement Obturator
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.