Medical device licence · 70329 · Class 2
SURGICAL SPONGE - COTTON
Yes: licensed in Canada
Licence status Issued (active); first licensed January 27, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 70329
- Licence holder
- Dukal LLCRonkonkoma, New York, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 27, 2006
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COTTON FILL X-RAY DETECTABLE ROUND STICK SPONGE - NON-STERILE
- COTTON FILL X-RAY DETECTABLE ROUND STICK SPONGE - STERILE
- PREWASHED X-RAY DETECTABLE LAPAROTOMY SPONGE - NON-STERILE
- PREWASHED X-RAY DETECTABLE LAPAROTOMY SPONGE - STERILE
- SPONGE, NS ROUND C-5 HOLDER
- STERILE ROUND DISSECTOR SPONGE
- STERILE SUPER STICK SPONGE
- UNWASHED X-RAY DETECTABLE LAPAROTOMY SPONGE - STERILE
- X-RAY DETECTABLE FLATSTICK SPONGE - NON-STERILE
- X-RAY DETECTABLE GAUZE - NON-STERILE
- X-RAY DETECTABLE GAUZE - STERILE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.