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510(k) Data Aggregation
K Number
K133632Device Name
PERICAN ULTRA
Manufacturer
B.BRAUN MEDICAL, INC
Date Cleared
2014-06-27
(213 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
B.BRAUN MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The B. Braun Perican Ultra needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.
Device Description
The B. Braun Perican Ultra needle is a single use, disposable anesthesia needle (18 Ga.) with Tuohy (curved) bevel. The needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter. The proposed needle is composed of a hollow stainless steel cannula with 1 cm depth markings along the length of the cannula. The cannula is also designed with small 'echogenic' etched markings intended to enhance visibility of the needle when using an ultrasound imaging device. The cannula are secured to the winged polycarbonate hub using an epoxy resin and plastic spacer. The Perican Ultra needle is provided with a plastic stylet, which is pre-assembled inside the needle cannula. The hub is designed with a Luer adapter to facilitate attachment of the needle to anesthetic administration devices, such as a syringe.
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