| Primary Device ID | 00810131881375 |
| NIH Device Record Key | 615e7e07-59c4-49f6-948a-ccba6984123a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALARA 11 Gauge Access Needle with Sheath - Bevel Tip |
| Version Model Number | AAN-11-S |
| Company DUNS | 004095409 |
| Company Name | SURGENTEC, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810131881375 [Primary] |
| GDF | Guide, Needle, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-07 |
| Device Publish Date | 2025-04-29 |
| 00810131881375 - ALARA 11 Gauge Access Needle with Sheath - Bevel Tip | 2025-05-07 |
| 00810131881375 - ALARA 11 Gauge Access Needle with Sheath - Bevel Tip | 2025-05-07 |
| 00810131881382 - ALARA 11 Gauge Access Needle with Sheath - Diamond Tip | 2025-05-07 |
| 00850040139471 - ALARA® 11 Gauge Access Needle - Bevel Tip | 2025-05-07 |
| 00850040139488 - ALARA® 11 Gauge Access Needle - Diamond Tip | 2025-05-07 |
| 00850040139495 - ALARA® 11 Gauge Access Needle Two Pack- Bevel Tip | 2025-05-07 |
| 00850040139501 - ALARA® 11 Gauge Access Needle Two Pack- Diamond & Bevel Tip | 2025-05-07 |
| 00850040139518 - ALARA® 11 Gauge Access Needle Two Pack- Diamond Tip | 2025-05-07 |
| 00850040139525 - ALARA® 11 Gauge Access Needle with Sheath - Bevel Tip | 2025-05-07 |