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Sterile Water Use Bacterostatic Water when: Multiple withdrawals from the same vial are planned Storage period between uses will exceed a few hours Working with peptides compatible with benzyl alcohol Conducting research requiring preserved multi-use preparations Use Sterile Water (preservative-free) when: Single-use application only Working with neonatal research models (benzyl alcohol contraindicated) Reconstituting compounds sensitive to benzyl alcohol Administering solutions intravenously (bacteriostatic agents contraindicated for IV use) Storage & Handling Storage Conditions Unopened vials: Store at controlled room temperature (20-25C / 68-77F) Opened vials: Refrigerate at 2-8C (36-46F) after first use Protect from: Freezing, excessive heat, direct light Shelf life (unopened): Refer to manufacturer expiration date (typically 2-3 years) Shelf life (opened): 28 days when refrigerated and handled with proper aseptic technique Proper Handling Protocol To maintain sterility and preservative efficacy: Always use aseptic technique Swab rubber stopper with 70% isopropyl alcohol before each entry Use sterile needles and syringes Never reuse needles or syringes Avoid contamination Do not touch needle tip or allow it to contact non-sterile surfaces Minimize air exposure Withdraw contents efficiently

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With respect to the newness criterion at 419.66(b)(1), the aprevo Cervical ACDF System received FDA Breakthrough Device designation effective September 15, 2023, under the name aprevo-C cervical interbody fusion device