FDA-Device2022-06-15Class II

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

ROi CPS LLC
Hazard

Potential for the tip of the electrode to detach during use.

Sold states
Distributed to North Carolina.
Affected count
125 units
Manufactured in
3000 E Sawyer Rd, Republic, MO, United States
Products
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2022

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