| Primary Device ID | 00810169722480 |
| NIH Device Record Key | dc972d71-a09f-4d43-baf0-de304e6c5040 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Indigo System Lightning Bolt 16 |
| Version Model Number | LITNGFB16H115H1-A |
| Catalog Number | LITNGFB16H115H1 |
| Company DUNS | 191077671 |
| Company Name | PENUMBRA, 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 | true |
| 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 | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com | |
| Phone | 1-888-272-4606 |
| info@penumbrainc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810169722480 [Primary] |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-02 |
| Device Publish Date | 2025-11-24 |
| 00810169722510 | Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select |
| 00810169722503 | Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 100cm XTORQ Tip, Selec |
| 00810169722497 | Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 100cm HTORQ Tip, Selec |
| 00810169722480 | Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 115cm HTORQ Tip, Selec |