Primary Device ID | 00840663110605 |
NIH Device Record Key | 33bbbaaa-795c-46e4-a667-c3869556da78 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CardioCel Neo Bioscaffold Patch 4 cm X 4 cm |
Version Model Number | UC0404N |
Company DUNS | 184805166 |
Company Name | Lemaitre Vascular, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | true |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840663110605 [Primary] |
DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-10-18 |
Device Publish Date | 2024-10-10 |
00840663110551 - CardioCel Bioscaffold Patch 4 cm X 4 cm | 2024-10-18 |
00840663110568 - CardioCel Bioscaffold Patch 5 cm X 8 cm | 2024-10-18 |
00840663110575 - CardioCel Bioscaffold Patch 6 cm X 14 cm | 2024-10-18 |
00840663110605 - CardioCel Neo Bioscaffold Patch 4 cm X 4 cm | 2024-10-18 |
00840663110605 - CardioCel Neo Bioscaffold Patch 4 cm X 4 cm | 2024-10-18 |
00840663110667 - VascuCel Bioscaffold Patch .8 cm X 8 cm | 2024-10-18 |
00840663110674 - VascuCel Bioscaffold Patch 1 cm X 14 cm | 2024-10-18 |
00840663110773 - CardioCel Neo Bioscaffold Patch 5 cm X 8 cm | 2024-10-18 |
00840663110544 - CardioCel Bioscaffold Patch 2 cm X 2 cm | 2024-10-16 |