| Primary Device ID | 00810024670277 |
| NIH Device Record Key | a3cd8ef8-7bc8-4637-8485-b9a88bb79e78 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dragonfly Digital Controller |
| Version Model Number | DFE-MD-000658 |
| Company DUNS | 117126091 |
| Company Name | CENTERPOINT SYSTEMS LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810024670277 [Primary] |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-30 |
| Device Publish Date | 2024-07-22 |
| 00810024670628 - AuST Steerable Sheath | 2024-09-30 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024670635 - AuST Steerable Sheath | 2024-09-30 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024670642 - AuST Steerable Sheath | 2024-09-30 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024670659 - AuST Steerable Sheath | 2024-09-30 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024670666 - AuST Steerable Sheath | 2024-09-30 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024670673 - AuST Steerable Sheath | 2024-09-30 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024670888 - AuST Steerable Sheath | 2024-09-30 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024670895 - AuST Steerable Sheath | 2024-09-30 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |