LATERA

GUDID 00857037006105

Latera 24 mm Delivery Device

ENTELLUS MEDICAL, INC.

Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer Nasal cartilage support implant introducer

• Primary Device ID: 00857037006105
• NIH Device Record Key: f13d3cac-647b-47c1-b262-524d73c3e1d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LATERA
• Version Model Number: LATDD24
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857037006105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161191

FDA Product Code

• NHB: Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-14
• Device Publish Date: 2017-09-19

On-Brand Devices [LATERA]

• 00857037006921: nasal implant delivery device
• 00857037006082: Latera 24mm Absorbable Nasal Implant
• 00857037006044: absorbable nasal implant
• 00857037006983: absorbable nasal implant
• 00857037006990: nasal implant delivery device
• 00857037006020: 20mm Latera Delivery Device
• 00857037006105: Latera 24 mm Delivery Device
• 00857037006037: Latera 20mm Absorbable Nasal Implant System
• 00857037006013: Latera 20mm Absorbable Nasal Implants
• 00857037006075: Latera 24mm Absorbable Nasal Implant System