Primary Device ID | 00850047730305 |
NIH Device Record Key | dfc2c30c-1e53-4249-8753-eb0b4248bd88 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Foundation DRS Solo |
Version Model Number | FS1-0003 |
Company DUNS | 080325588 |
Company Name | Bionova Medical 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 | 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 | true |
OTC Over-The-Counter | false |
Phone | 901-7482581 |
info@bionovamedical.com | |
Phone | 901-7482581 |
info@bionovamedical.com | |
Phone | 901-7482581 |
info@bionovamedical.com | |
Phone | 901-7482581 |
info@bionovamedical.com | |
Phone | 901-7482581 |
info@bionovamedical.com | |
Phone | 901-7482581 |
info@bionovamedical.com | |
Phone | 901-7482581 |
info@bionovamedical.com | |
Phone | 901-7482581 |
info@bionovamedical.com |
Area/Surface Area | 3 Square centimeter |
Area/Surface Area | 3 Square centimeter |
Area/Surface Area | 3 Square centimeter |
Area/Surface Area | 3 Square centimeter |
Area/Surface Area | 3 Square centimeter |
Area/Surface Area | 3 Square centimeter |
Area/Surface Area | 3 Square centimeter |
Area/Surface Area | 3 Square centimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850047730305 [Primary] |
FTM | Mesh, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-09-25 |
Device Publish Date | 2025-09-17 |
00850047730077 | Fenestrated |
00850047730060 | Fenestrated |
00850047730053 | Fenestrated |
00850047730046 | Fenestrated |
00850047730039 | FS1-2025 |
00850047730022 | FS1-1025 |
00850047730015 | FS1-1012 |
00850047730008 | FS1-0505 |
00850047730343 | FS1-20252 |
00850047730336 | FS1-0404 |
00850047730329 | FS1-0203 |
00850047730312 | FS1-0009 |
00850047730305 | FS1-0003 |