| Primary Device ID | 15420045504592 |
| NIH Device Record Key | bd46b9b0-277c-4d28-85a3-94b20ad19d61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATEC Introducer |
| Version Model Number | AI121220 |
| Catalog Number | AI121220 |
| Company DUNS | 018925968 |
| Company Name | Hologic, 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045504592 [Primary] |
| GS1 | 25420045504599 [Package] Package: BOX [5 Units] In Commercial Distribution |
| KNW | INSTRUMENT, BIOPSY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
[15420045504592]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-11 |
| 05420045503796 | ILS 0914-12-OB |
| 05420045503789 | ILS 0914-20-OB |
| 05420045503208 | ILS 0914-20 |
| 05420045503192 | ILS 0914-12 |
| 15420045504592 | AI121220 |
| 15420045504585 | AI120920 |
| 15420045504578 | AI091220 |
| 15420045504561 | AI090920 |