FDA-Device2023-05-10Class II
CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01
Beaver Visitec International, Inc.
Hazard
Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.
Sold states
US Nationwide distribution.
Affected count
501 (USA)
Manufactured in
500 Totten Pond Rd, 10 City Point, Waltham, MA, United States
Products
CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2023Don't want to check this manually?
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