| Primary Device ID | 00613994609908 |
| NIH Device Record Key | 5146ceff-0acc-466d-a776-673584f1ad33 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 3550-69 |
| Company DUNS | 796986144 |
| Company Name | MEDTRONIC, INC. |
| 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 | 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 |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994609908 [Primary] |
| HAO | INSTRUMENT, SURGICAL, NON-POWERED |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-11-18 |
| 00199150009114 - NA | 2025-09-15 CUSTOM PACK BB10Z98R7 PED E |
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| 20199150044515 - NA | 2025-09-15 CUSTOM PACK BB12N37R1 5PK LOWER LMB |
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| 00199150044665 - NA | 2025-09-15 CUSTOM PACK BB12E50R5 HLO SPECT PUM |
| 20199150045222 - NA | 2025-09-15 CUSTOM PACK 12R69R 10PK EVL |