Home GUDID 00887919587361 Brasseler USA
Primary DI 00887919587361
Brand Brasseler USA
Company Peter Brasseler Holdings, LLC
Model 5014286U0
Device description KU15 NYU 9107.634.035 KIT 1P
Published 2022-12-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00887919587361 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00887919587361 00887919587361 887919587361 0887919587361
GMDN Terms# Term, Definition table Term Definition Manual endodontic file/rasp, single-use A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 082080136 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company#