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Brief exposure (under 30 minutes) during dose preparation is fine

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Please note: For Intramuscular (IM) or Intravenous (IV) use only Store away from direct sunlight 1 ~ 25C Keep out of sight and reach of children Not intended to diagnose, treat, cure or prevent any disease, for promoting wellness only This is a single use ampoule, once opened, use immediately and discard any product not used All products are for sale to trained and insured professionals only who are 18+ years of age

The applicant asserted its belief that the nominated device offers a meaningful advancement for patients with challenging peripheral nerve injuries and that it meets the regulatory criteria for a transitional pass-through payment under 419.66