FDA-Device2021-04-14Class II

Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)

Tenderneeds Fertility LLC
Hazard

Device was distributed without a proper marketing authorization.

Sold states
World-wide distribution.
Affected count
Unknown
Manufactured in
10162 Bradford Rd, N/A, Greenville, IN, United States
Products
Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1361-2021

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