| Primary Device ID | 00851677007072 |
| NIH Device Record Key | 3371375d-60a1-4acd-82fd-8cfe232e96d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standard Bougie, 38Fr |
| Version Model Number | SB38 |
| Company DUNS | 091278068 |
| Company Name | STANDARD BARIATRICS, INC |
| Device Count | 1 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851677007065 [Primary] |
| GS1 | 00851677007072 [Package] Contains: 00851677007065 Package: [6 Units] In Commercial Distribution |
| KNT | Tubes, Gastrointestinal (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-26 |
| Device Publish Date | 2021-08-18 |
| 00851677007164 - Titan SGS Standard Gastric Stapler | 2023-10-31 |
| 10851677007123 - Standard Tapered Bougie, 38Fr | 2022-12-06 |
| 00851677007133 - Titan SGS Standard Gastric Stapler | 2022-06-10 |
| 10851677007116 - Standard Bougie Handpump | 2021-12-30 |
| 00851677007072 - Standard Bougie, 38Fr | 2021-08-26 |
| 00851677007072 - Standard Bougie, 38Fr | 2021-08-26 |
| 00851677007089 - Titan SGS Standard Gastric Stapler | 2021-08-26 |
| 00851677007096 - TITAN Standard Power Unit | 2021-08-26 |
| 10851677007048 - Standard Trocar | 2020-05-05 |