Home GUDID M61034050771 Integra®
Primary DI M61034050771
Brand Integra®
Company INTEGRA PAIN MANAGEMENT
Model 3405077
Device description PATIENT PREP KIT
Published 2016-10-03
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780265672 Primary GS1 0 M61034050771 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780265672 10381780265672
GMDN Terms# Term, Definition table Term Definition Surgical patient preparation kit A collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Storage Environment Temperature: 15 C to 30 C (59 F to 86 F)
Regulatory Flags# DUNS number 030370299 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product true Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# 
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