| Primary Device ID | 00816849019277 |
| NIH Device Record Key | f8585df5-3652-4804-a0f7-5acf20e82d57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neptune® |
| Version Model Number | DNX-446 |
| 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 |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816849019260 [Unit of Use] |
| GS1 | 00816849019277 [Primary] |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology |
| 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 |
| 00816849019277 | 25 Gauge (0.5 mm) Injection Needle |
| 00816849019253 | 22 Gauge (0.7 mm) Injection Needle |