| Primary Device ID | 25060238200350 |
| NIH Device Record Key | d397d743-9efe-46ab-8856-f3e0425c61e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Femoral Cement Pressuriser |
| Version Model Number | P721 |
| Company DUNS | 221751311 |
| Company Name | SUMMIT MEDICAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15060238200353 [Primary] |
| GS1 | 25060238200350 [Package] Contains: 15060238200353 Package: Carton [10 Units] In Commercial Distribution |
| HWN | Instrument, Compression |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-09 |
| Device Publish Date | 2021-12-01 |
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