| Primary Device ID | 00810024670291 |
| NIH Device Record Key | d7691b62-5a4f-46a6-b702-9d2445c42e2c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helix Locking Tool |
| Version Model Number | 5616 |
| Company DUNS | 117126091 |
| Company Name | CENTERPOINT SYSTEMS LLC |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com | |
| Phone | 877-848-0828 |
| info@centerpoint-systems.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810024670291 [Primary] |
| GS1 | 10810024670298 [Unit of Use] |
| DWS | Instruments, Surgical, Cardiovascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-25 |
| Device Publish Date | 2024-03-15 |
| 00810024671199 - AuST Steerable Sheath | 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024671205 - AuST Steerable Sheath | 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024671212 - AuST Steerable Sheath | 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024671229 - AuST Steerable Sheath | 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024671236 - AuST Steerable Sheath | 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024671243 - AuST Steerable Sheath | 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024671250 - AuST Steerable Sheath | 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |
| 00810024671267 - AuST Steerable Sheath | 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc |