| Primary Device ID | 08800041000074 |
| NIH Device Record Key | e7332a7e-7b16-43db-bfb9-bbeb68cbcf0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GBR System |
| Version Model Number | SDS-140-120 |
| Company DUNS | 689846448 |
| Company Name | Surgident Co.,Ltd. |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | 08800041000074 [Primary] |
| GS1 | 08800041000333 [Unit of Use] |
| DZL | Screw, Fixation, Intraosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800041000074]
Moist Heat or Steam Sterilization
[08800041000074]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-11 |
| Device Publish Date | 2018-08-31 |
| 08800041000258 | SDP-T44-044 |
| 08800041000241 | SDP-T36-022 |
| 08800041000234 | SDP-T22-015 |
| 08800041000227 | SDP-S44-044 |
| 08800041000210 | SDP-S36-022 |
| 08800041000203 | SDP-S22-015 |
| 08800041000197 | SDS-200-120 |
| 08800041000180 | SDS-200-100 |
| 08800041000173 | SDS-200-080 |
| 08800041000166 | SDS-200-060 |
| 08800041000159 | SDS-200-040 |
| 08800041000142 | SDS-200-030 |
| 08800041000135 | SDS-160-120 |
| 08800041000128 | SDS-160-100 |
| 08800041000111 | SDS-160-080 |
| 08800041000104 | SDS-160-060 |
| 08800041000098 | SDS-160-040 |
| 08800041000081 | SDS-160-030 |
| 08800041000074 | SDS-140-120 |
| 08800041000067 | SDS-140-100 |
| 08800041000050 | SDS-140-080 |
| 08800041000043 | SDS-140-060 |
| 08800041000036 | SDS-140-040 |
| 08800041000029 | SDS-140-030 |
| 08800041000012 | SDB-140-050 |
| 08800041000005 | SDB-140-035 |