| Primary Device ID | 14953170042369 |
| NIH Device Record Key | ca8fff54-cbb7-4d79-97cf-18d08a763c8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME |
| Version Model Number | KD-431Q-0720 |
| Company DUNS | 711789789 |
| Company Name | OLYMPUS MEDICAL SYSTEMS CORP. |
| 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 | false |
| 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 | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170042362 [Primary] |
| GS1 | 14953170042369 [Package] Contains: 04953170042362 Package: [1 Units] In Commercial Distribution |
| KNS | Unit, electrosurgical, endoscopic (with or without accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2016-09-21 |
| 14953170042390 | KD-431Q-0730 |
| 14953170042369 | KD-431Q-0720 |
| 14953170042062 | KD-411Q-0320 |
| 14953170042000 | KD-411Q-0320 |
| 14953170041942 | KD-411Q-0320 |
| 14953170041706 | KD-401Q-0730 |
| 14953170041645 | KD-401Q-0720 |
| 14953170041614 | KD-401Q-0330 |
| 14953170041584 | KD-401Q-0320 |
| 14953170464567 | KD-411Q-0320 |
| 14953170463775 | KD-431Q-0720 |
| 14953170463768 | KD-411Q-0320 |