LATERA

Basic Information

• Brand Name: LATERA
• Primary DI: 00857037006075
• Version / Model: LATSYS24
• Company Name: ENTELLUS MEDICAL, INC.
• Labeler DUNS: 017283879
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-14
• Public Version: 2
• Public Version Date: 2023-07-07
• Public Version Status: Update
• Public Device Record Key: 536ca89a-7878-45c8-8f9b-355361030d18

Device Description

Absorbable Nasal Implant System 24mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62157	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.	Yes	Active
62156	Nasal implant introducer	A sterile, hand-held manual surgical instrument intended to be used to introduce a nasal implant into the nasal soft tissues (e.g., between the nasal mucosa and the cartilage). It is in the form of a syringe-like tool with a plunger and a stainless steel cannula designed to be inserted through the nasal mucosa tissue, via the nasal cavity, to deploy the implant. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857037006075	GS1

Premarket Submissions

Submission Number	Supplement Number
K161191	000

Device Sizes

Type	Value	Unit	Text
Length	24	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 38 Degrees Celsius