Primary Device ID | D040600130 |
NIH Device Record Key | e5274889-ecec-4ff2-8891-63b29295a97c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ARDENT |
Version Model Number | 60013 |
Company DUNS | 006385173 |
Company Name | WHIP-MIX CORPORATION |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D040600130 [Primary] |
EFH | Paper, Articulation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-06 |
Device Publish Date | 2023-10-27 |
D040602061 | Ardent™ Exacta-Film Red/Black |
D040600130 | Ardent™ Complete Kit- Trial Kit |
D040600081 | Ardent™ Articulating Paper Quadrant Red Blue Curved .0025 144 Strips 63 microns |