| Primary Device ID | 00842429103401 | 
| NIH Device Record Key | 9491e527-7af3-4500-b259-dfed7d3e42da | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Balloon Catheter | 
| Version Model Number | BC0420C-ID-700 | 
| Catalog Number | BC0420C | 
| Company DUNS | 003263105 | 
| Company Name | MICROVENTION 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 | true | 
| 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 Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00842429103401 [Primary] | 
| DQY | Catheter, percutaneous | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-06-22 | 
| Device Publish Date | 2022-06-14 | 
| 00842429106563 | Scepter Mini | 
| 00842429103418 | Scepter XC | 
| 00842429103401 | Scepter C | 
| 00842429103395 | Scepter C | 
| 00842429103388 | Scepter C | 
| 00842429106945 | Scepter XC | 
| 00842429106907 | Scepter C | 
| 00842429106891 | Scepter C | 
| 00842429106884 | Scepter C |