| Primary Device ID | 00815948022843 |
| NIH Device Record Key | 7b4a12d8-0351-47c6-be5b-6e031924eaaf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE |
| Version Model Number | 5MAXACE068-R |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815948022843 [Primary] |
| NRY | CATHETER, THROMBUS RETRIEVER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-14 |
| Device Publish Date | 2020-05-06 |
| 00814548016603 | 5MAXACE068KIT |
| 00814548016535 | 5MAXACE068 |
| 00814548016528 | 5MAXACE068L127 |
| 00814548016511 | 5MAXACE068L125 |
| 00814548016504 | 5MAXACE068L120 |
| 00814548016498 | 5MAXACE068L115 |
| 00814548016467 | 5MAXACE064KIT |
| 00814548014005 | RC ACE 64, 127cm |
| 00814548013992 | RC ACE 64, 125cm |
| 00814548013985 | RC ACE 64, 120cm |
| 00814548013978 | RC ACE 64, 115cm |
| 00814548013961 | RC ACE 64, 132cm |
| 00815948022850 | 5MAXACE068KIT |
| 00815948022843 | 5MAXACE068 |