| Primary Device ID | 40616258010227 |
| NIH Device Record Key | ecd9ee29-4fd5-4db4-add2-8b28dfce3174 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avanta Hand Controller Sheath |
| Version Model Number | AVA 500 HCS |
| Catalog Number | AVA 500 HCS |
| Company DUNS | 058716649 |
| Company Name | BAYER MEDICAL CARE 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616258010229 [Primary] |
| GS1 | 40616258010227 [Package] Contains: 00616258010229 Package: [25 Units] In Commercial Distribution |
| DXT | Injector And Syringe, Angiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2019-05-20 |
| 40616258010227 | Avanta Single Use Hand Controller Sheath (SHEATH,HAND CONTROLLER,MC, JA2)( 85239066) |
| 40616258021544 | SHEATH,HAND CONTROLLER,MC,WLD (86566753) |
| 40616258024903 | SHEATH,HAND CONTROLLER,MC,CORE (87640612) |