FDA-Device2013-03-06Class II

Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.

Integra LifeSciences Corp.
Hazard

Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.

Sold states
Worldwide Distribution - USA Nationwide including Canada.
Affected count
22,500
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0886-2013

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