| 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 |
| 00643169281110 - CD HORIZON® ASTUTE™ SPINAL SYSTEM | 2024-05-10 PEEK ROD 1608451035 6.0 X 6.9MM STR 35MM |
| 00643169281264 - CD HORIZON® ASTUTE™ SPINAL SYSTEM | 2024-05-10 PEEK ROD 1608451090 6.0 X 6.9MM STR 90MM |
| 00763000917982 - Medtronic Reusable Instruments | 2024-05-06 DEROTATOR EX0923006 APICAL 5.5/6.0 |
| 00763000919658 - Medtronic Reusable Instruments | 2024-05-06 RASP EX1023210 LS SMALL 12DEG 32X25X10MM |
| 00763000919665 - Medtronic Reusable Instruments | 2024-05-06 RASP EX1023212 LS SMALL 12DEG 32X25X12MM |
| 00763000919672 - Medtronic Reusable Instruments | 2024-05-06 RASP EX1023110 TL 12DEG 20W 10X60MM |
| 00763000919689 - Medtronic Reusable Instruments | 2024-05-06 RASP EX1023112 TL 12DEG 20W 12X60MM |
| 00763000940362 - Medtronic Reusable Instruments | 2024-05-06 TRIAL X0420004 16DEG 10MM STANDARD |