Blu K-Style Sinus Pack' 3.5 cm x .9 cm x 1.2 cm, Bacteriostatic

GUDID 00821925029965

Gyrus Acmi, Inc.

Intranasal splint, non-biodegradable

• Primary Device ID: 00821925029965
• NIH Device Record Key: 97d56b96-1c3f-4be4-9c71-d6c4929fb593
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blu K-Style Sinus Pack' 3.5 cm x .9 cm x 1.2 cm, Bacteriostatic
• Version Model Number: 7089-0844
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00821925029965 [Package]; Contains: 00821925034853; Package: [10 Units]; In Commercial Distribution
GS1	00821925034853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983276

FDA Product Code

• EMX: BALLOON, EPISTAXIS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-10
• Device Publish Date: 2018-09-13