Home GUDID 00857037006983 LATERA
Primary DI 00857037006983
Brand LATERA
Company ENTELLUS MEDICAL, INC.
Model LATANI01
Device description absorbable nasal implant
Published 2016-07-21
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 NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00857037006983 Package GS1 6 In Commercial Distribution 00857037006020 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 00857037006983 00857037006983 857037006983 0857037006983 00857037006020 00857037006020 857037006020 0857037006020
GMDN Terms# Term, Definition table Term Definition Nasal implant, synthetic polymer, bioabsorbable A sterile bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose by providing structural support to the cartilage to prevent nasal obstruction. It is a shaped device made of synthetic polymer materials [e.g., poly(L-lactide-co-D, L-lactide)] designed to gradually disintegrate following implantation. Dedicated devices intended to assist implantation through puncture of mucosal tissues may be included.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 017283879 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00857326005536 XeroGel XG-102 2020-09-10 00857326005543 XeroGel XG-108 2020-09-10 10850002250210 Shaver Blade 2.1mm Reusable Double Serrated Straight SSB-222-0 2020-09-25 10857326005731 Shaver Blade 3mm Reusable Double Serrated Straight SSB-223-0 2020-09-25 10857326005748 Shaver Blade 4mm Reusable Double Serrated Straight SSB-224-0 2020-09-25 10857326005755 Shaver Blade 3mm Single Use Double Serrated Straight SSB-12300-1, SSB-12300-5 2020-09-25 10857326005762 Shaver Blade 3mm Single Use Double Serrated 40° SSB-12340-1, SSB-12340-5 2020-09-25 10857326005779 Shaver Blade 3mm Single Use Double Serrated 60° SSB-12360-1, SSB-12360-5 2020-09-25 10857326005786 Shaver Blade 4mm Single Use Double Serrated Straight SSB-12400-1, SSB-12400-5 2020-09-25 10857326005793 Shaver Blade 4mm Single Use Double Serrated 40° SSB-12440-1, SSB-12440-5 2020-09-25 10857326005809 Shaver Blade 4mm Single Use Double Serrated 60° SSB-12460-1, SSB-12460-5 2020-09-25 10857326005830 Shaver Blade 2.1mm Single Use Double Serrated Straight SSB-12200-1, SSB-12200-5 2020-09-25 00857326005550 Entellus Medical Reinforced Anesthesia Needle RAN RAN-027-2 2017-05-18 00857326005574 Entellus Medical Reinforced Anesthesia Needle RAN RAN-027-5 2017-05-18 00857037006990 LATERA LATDD01 2016-07-21 00857037006921 LATERA LATDD24 2017-09-19
Other Devices Sharing Product Codes#