Medical device licence · 87191 · Class 4
BIODESIGN FISTULA PLUG
Yes: licensed in Canada
Licence status Issued (active); first licensed September 16, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 87191
- Licence holder
- Cook Biotech Inc.West Lafayette, IN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Group Family
- First licensed
- September 16, 2011
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIODESIGN FISTULA PLUG
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “biodesign”. A notice may cover another product or only some lots: read it to see what it covers.
- Biodesign® Hiatal Hernia GraftDecember 19, 2024 · General and plastic surgery · Labelling and packaging · Type II
- Biodesign® Fistula PlugAugust 21, 2024 · General and plastic surgery · Labelling and packaging · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.