Medical device licence · 105297 · Class 3
FIBERSTITCH
Yes: licensed in Canada
Licence status Issued (active); first licensed October 15, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105297
- Licence holder
- T.A.G. Medical Products Corporation Ltd.Kibbutz Gaaton, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- October 15, 2020
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FIBERSTITCH IMPLANT 1.5, CURVED (RC) WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, CURVED 24 DEGREES WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, REVERSE WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, SIMPLE CURVED RC WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, SIMPLE STRAIGHT RC WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, STRAIGHT (RC) WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, STRAIGHT WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- MENISCAL REPAIR DEVICE 24DEG CURVE WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- MENISCAL REPAIR DEVICE CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- MENISCAL REPAIR DEVICE REVERSE CURVE WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- MENISCAL REPAIR DEVICE STRAIGHT WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.