Novapak

GUDID 00643169662254

NASAL PACKING CS3900-10 NOVAPAK 10PK FRM

MEDTRONIC XOMED, INC.

ENT space-occupying dressing, animal-derived

• Primary Device ID: 00643169662254
• NIH Device Record Key: 77faebe3-d0f5-4822-ae79-86102af5c978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novapak
• Version Model Number: CS3900-10
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 10
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store Novapak at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169662254 [Unit of Use]
GS1	20643169662258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202623

FDA Product Code

• LYA: SPLINT, INTRANASAL SEPTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-16
• Device Publish Date: 2021-02-08

On-Brand Devices [Novapak]

• 00643169662254: NASAL PACKING CS3900-10 NOVAPAK 10PK FRM
• 00643169662247: NASAL PACKING CS3600-10 NOVAPAK 10PK STD
• 00643169662230: NASAL PACKING CS3900-2 NOVAPAK 2PK FRM
• 00643169662223: NASAL PACKING CS3600-2 NOVAPAK 2PK STD