| Primary Device ID | 00816849017600 |
| NIH Device Record Key | 6b1dcd27-657f-4b93-83b2-93729ae9322d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Boa® |
| Version Model Number | DSO-013 |
| Company DUNS | 014154279 |
| Company Name | ENDOCHOICE, INC. |
| Device Count | 10 |
| 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 |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com | |
| Phone | 888-632-3636 |
| customercare@endochoice.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816849017594 [Unit of Use] |
| GS1 | 00816849017600 [Primary] |
| FDI | Snare, Flexible |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-06-21 |
| Device Publish Date | 2016-09-08 |
| 10840253110067 - Seal® | 2023-06-27 Biopsy Valve |
| 00840253101211 - Fuse® | 2019-11-27 Water bottle cap, reusable |
| 00840253101228 - Fuse® | 2019-11-27 Water bottle cap with CO2, Reusable |
| 00840253111173 - Fuse | 2019-11-27 Reusable Water Bottle |
| 00840253111180 - Fuse | 2019-11-27 Reusable Water Bottle with CO2 |
| 00816849017303 - Rescue® | 2019-08-21 Alligator Grasping Forceps |
| 00816849017310 - Rescue® | 2019-08-21 Alligator Grasping Forceps , Long |
| 00816849017327 - Rescue® | 2019-08-21 Rat tooth/Alligator Grasping Forceps |