Primary Device ID | 15420045506855 |
NIH Device Record Key | 2a39032c-8d30-400a-83da-9da50908c754 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ATEC PEARL |
Version Model Number | ATEC PEARL |
Company DUNS | 018925968 |
Company Name | Hologic, Inc. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 15420045506855 [Primary] |
KNW | INSTRUMENT, BIOPSY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-30 |
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