Medical device licence · 82885 · Class 4
BACTISEAL UNIVERSAL SHUNT
Yes: licensed in Canada
Licence status Issued (active); first licensed May 20, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82885
- Licence holder
- Integra Lifesciences Production CorporationMansfield, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Group Family
- First licensed
- May 20, 2010
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BACTISEAL UNIV. SHUNT, TWO-PIECE SHUNT W/RESERVOIR PERFORMANCE RANGE: HIGH
- BACTISEAL UNIV. SHUNT, TWO-PIECE SHUNT W/RESERVOIR PERFORMANCE RANGE: LOW
- BACTISEAL UNIV. SHUNT, TWO-PIECE SHUNT W/RESERVOIR PERFORMANCE RANGE:MEDIUM
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 “bactiseal”. A notice may cover another product or only some lots: read it to see what it covers.
- Codman Bactiseal EVD Catheter SetMay 29, 2024 · Neurology · Sterility · Type II
- BACTISEAL EVD Catheter Set, CODMAN Peritoneal Catheter, Ventricular and Peritoneal Catheter Set, CODMAN Ventricular Catheter with BACTISEAL (2019-03-14)April 29, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.