| Primary Device ID | 00858836007102 |
| NIH Device Record Key | 87fd2438-273a-4505-88a8-35f50923bce2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DiLumen Interventional Grasper |
| Version Model Number | IgE 125cm |
| Catalog Number | D-3010 |
| Company DUNS | 859290897 |
| Company Name | LUMENDI LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858836007102 [Primary] |
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-02 |
| Device Publish Date | 2020-08-25 |
| 00858836007164 - DiLumen C1, 130 cm | 2023-05-09 The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, |
| 00858836007171 - DiLumen EZ1, 130 cm | 2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine |
| 00858836007188 - DiLumen C1, 103 cm | 2023-05-09 The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, |
| 00858836007195 - DiLumen EZ1, 103 cm | 2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine |
| 00858836007102 - DiLumen Interventional Grasper | 2020-09-02125 cm flexible shaft grasper with elbow bending section and articulating distal tip |
| 00858836007102 - DiLumen Interventional Grasper | 2020-09-02 125 cm flexible shaft grasper with elbow bending section and articulating distal tip |
| 00858836007041 - DiLumen Ik Endolumenal Interventional Knife | 2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend |
| 00858836007058 - DiLumen Ik Endolumenal Interventional Knife | 2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend |
| 00858836007065 - DiLumen C2 | 2020-01-03 DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind th |