Standard Trocar
GUDID 10851677007048
STANDARD BARIATRICS, INC
Laparoscopic access cannula, single-use| Primary Device ID | 10851677007048 |
| NIH Device Record Key | e225376e-2d0a-47b6-b263-861c4e5aa802 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standard Trocar |
| Version Model Number | ST19-1 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851677007041 [Primary] |
| GS1 | 10851677007048 [Package] Contains: 00851677007041 Package: [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200517
FDA Product Code
| GCJ | Laparoscope, General & Plastic Surgery |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-05 |
| Device Publish Date | 2020-04-27 |
Devices Manufactured by STANDARD BARIATRICS, INC
| 10851677007109 - Titan SGS Bailout Chuck | 2024-07-22 Titan SGS Bailout Chuck |
| 00851677007140 - Atlas SSLR Buttress Assembly | 2024-07-18 Atlas SSLR Buttress Assembly |
| 00851677007171 - Standard Precision Bougie Device | 2024-07-11 Standard Precision Bougie Device Non-Sterile 38Fr |
| 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 |
Trademark Results [Standard Trocar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STANDARD TROCAR 88878000 not registered Live/Pending |
Standard Bariatrics, Inc. 2020-04-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.