Medical device licence · 15560 · Class 2
DILATOR AND ACCESS SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 6, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 15560
- Licence holder
- Cook, IncorporatedBloomington, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- January 6, 2000
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMPLATZ RENAL DILATOR SET
- AMPLATZ RENAL DILATORS WITH SHEATHS
- CURVED URETHRAL DILATOR SET
- FACIAL DILATOR SETS
- FLEXOR URETERAL ACCESS SHEATH WITH AQ HYDROPHILIC COATING
- TEFLON FASCIAL DILATOR SET
- TUNNER PEDIATRIC URETHRAL DILATOR SET
- URETERAL DILATOR SETS
- URETERAL TEFLON DILATOR SET
- URETHRAL DILATION AND ACCESS SET
- URETHRAL DILATOR SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.