FDA-Device2021-05-05Class II
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
Hazard
failed rivet at the chafe tab of arm sling.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
Affected count
N/A
Manufactured in
Carretera Libre Tijuana-Tecate, 20230 Submetropoli El Florido, Tijuana, N/A, Mexico
Products
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2021Don't want to check this manually?
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