BD Whitacre Pencil Point Spinal Needle 22 27G

Certifications

• CE Marked medical device under EU medical device regulations (Whitacre spinal needle family, including size 27G x 119 mm).
• FDA 510(k) Cleared in the United States as an anaesthesia conduction needle under 21 CFR 868.5150 (Whitacre spinal needle family).
• Class II device in the United States; treated as high Risk class (e.g. Class III) in some EU regulatory documentation.
• Manufactured under an ISO 13485:2016 Certified quality management system.
• Conforms to international standards for sterile, single Use hypodermic and spinal needles, including colour coding of hubs per ISO 6009.