| Primary Device ID | 00860009430235 |
| NIH Device Record Key | 49e530a7-6df1-4f7c-b4c4-caf8ec7ba2ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adapter SRA-1-01 |
| Version Model Number | SRA-1-01 |
| Company DUNS | 118905661 |
| Company Name | SERPEX MEDICAL 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 | 00860009430235 [Primary] |
| GS1 | 10860009430232 [Package] Package: [10 Units] In Commercial Distribution |
| KTI | Bronchoscope Accessory |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-16 |
| Device Publish Date | 2025-12-08 |
| 00860009430204 - Recon Steerable Sheath | 2025-12-16 The Recon Steerable Sheath is a sterile, single use transbronchial sheath with a unidirectional, steerable distal tip that provi |
| 00860009430211 - Compass Steerable Needle | 2025-12-16 The Compass Steerable Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a unidirectional, steerable dista |
| 00860009430235 - Adapter SRA-1-01 | 2025-12-16 Adapter SRA-1-01 connects the Model CSN1002 to the Ion™ Endoluminal System |
| 00860009430235 - Adapter SRA-1-01 | 2025-12-16 Adapter SRA-1-01 connects the Model CSN1002 to the Ion™ Endoluminal System |
| 10860009430249 - Adapter SRA-2-01 | 2025-12-16 Adapter SRA-2-01 connects the Model CSN1002 to the Monarch™ Platform or Galaxy System™ |
| 00860009430228 - Compass Steerable Needle | 2023-03-27 Transbronchial Biopsy Needle |