FDA-Device2018-05-16Class II
ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Microline Surgical, Inc.
Hazard
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Sold states
Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
Affected count
12 box of 10 tips each
Manufactured in
50 Dunham Rd, Suite 1500, Beverly, MA, United States
Products
ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1740-2018Don't want to check this manually?
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