Home GUDID 20817470006456
ENT Sinus
Primary DI 20817470006456
Brand ENT Sinus
Company Smith & Nephew, Inc.
Model 601-00100
Catalog number 601-00100
Device description ENTACT SEPTAL STAPLER 3-PACK
Published 2015-08-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name OLL Septal Stapler/Absorbable staples
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLL Septal Stapler/Absorbable Staples General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20817470006456 Package GS1 3 In Commercial Distribution 00817470006452 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 20817470006456 20817470006456 00817470006452 00817470006452 817470006452 0817470006452
GMDN Terms# Term, Definition table Term Definition Intranasal splint, biodegradable A bioabsorbable device intended to be placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and provide support to the surrounding tissues during the healing period. It is made of non-animal source material which chemically degrades after about 3 – 4 weeks and is absorbed via natural body processes, or it may be removed at the discretion of the physician. This is a single-use device.
Regulatory Flags# DUNS number 109903521 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false 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 false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00817470006452 ENT Sinus Smith & Nephew, Inc. OLL 2015-08-30 00817470006469 ENT Sinus Smith & Nephew, Inc. OLL 2015-08-30