| Primary Device ID | 00763000557065 |
| NIH Device Record Key | 87ea10e3-43de-40f6-a647-86bbac16a2c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SYRINGE ATR INFLATION HP |
| Version Model Number | A08E-ATR |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000557065 [Primary] |
| DXT | Injector and syringe, angiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-12 |
| Device Publish Date | 2023-06-03 |
| 00199150007523 - Medtronic Reusable Instruments | 2025-08-12 EXPANDER X981000227 LATERAL PARALLEL |
| 00199150007530 - Medtronic Reusable Instruments | 2025-08-12 EXPANDER X981000270 LATERAL PROXIMAL |
| 00643169588066 - n/a | 2025-08-12 DRIVER 7376007 LOCKSCREW DRIVER |
| 00763000875220 - SHILLA™ Growth Guidance System | 2025-08-12 SET SCREW 7675501 5.5 SHILLA STANDARD |
| 00673978064710 - n/a | 2025-08-11 INSTRUMENT 8616008 SHAFT FOR DISMANTLING |
| 00763000664145 - ZEVO™ Anterior Cervical Plate System | 2025-08-11 PLATE G3005105 ZEVO 105MM 5 LVL |
| 00763000673796 - n/a | 2025-08-11 INSTRUMENT 8968004 RETRACTABLE AWL |
| 00763000879570 - Endoskeleton™ TCS Interbody System | 2025-08-11 MALLET 5210-1003 TCS MALLET |