Primary Device ID | B040ASR19210 |
NIH Device Record Key | f73e47f2-61f9-444d-9842-c91640439a8f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Annular Sizer Aortic |
Version Model Number | ASR19/21 |
Company DUNS | 939872651 |
Company Name | GENESEE BIOMEDICAL, 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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B040ASR1921 [Package] Package: [1 Units] In Commercial Distribution |
HIBCC | B040ASR19210 [Primary] |
DWS | Instruments, Surgical, Cardiovascular |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B040ASR19210]
Moist Heat or Steam Sterilization
[B040ASR19210]
Moist Heat or Steam Sterilization
[B040ASR19210]
Moist Heat or Steam Sterilization
[B040ASR19210]
Moist Heat or Steam Sterilization
[B040ASR19210]
Moist Heat or Steam Sterilization
[B040ASR19210]
Moist Heat or Steam Sterilization
[B040ASR19210]
Moist Heat or Steam Sterilization
[B040ASR19210]
Moist Heat or Steam Sterilization
[B040ASR19210]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-13 |
Device Publish Date | 2024-12-05 |
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B040ASR2325 | Aortic Repair Tool Kit - Annular Sizers |
B040ASR19210 | Aortic Repair Tool Kit - Annular Sizers |