LATERA

GUDID 00857037006921

nasal implant delivery device

ENTELLUS MEDICAL, INC.

Nasal implant introducer

• Primary Device ID: 00857037006921
• 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]
GS1	00857037006921 [Package]; Contains: 00857037006105; Package: [6 Units]; In Commercial Distribution

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: 4
• Public Version Date: 2019-02-14
• 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