RELIEVA SCOUT SCT0624MFS

GUDID 20705031238036

RELIEVA SCOUT MULTI-SINUS DILATION SYSTEM

ACCLARENT, INC.

Epistaxsis balloon Epistaxis balloon Epistaxis balloon Epistaxis balloon Epistaxis balloon Epistaxis balloon Epistaxis balloon Epistaxis balloon Epistaxis balloon Epistaxis balloon Epistaxis balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon

• Primary Device ID: 20705031238036
• NIH Device Record Key: 009acb9d-32c7-429b-b04c-22f998287a44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIEVA SCOUT
• Version Model Number: SCT0624MFS
• Catalog Number: SCT0624MFS
• Company DUNS: 361092450
• Company Name: ACCLARENT, 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: true
• 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

Customer Support Contacts

• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031238039 [Primary]
GS1	20705031238036 [Package]; Contains: 10705031238039; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153341

FDA Product Code

• LRC: INSTRUMENT, ENT MANUAL SURGICAL

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: 2020-01-22
• Device Publish Date: 2016-10-01

On-Brand Devices [RELIEVA SCOUT]

• 20705031237831: RELIEVA SCOUT MULTI-SINUS DILATION SYSTEM, 1 PK
• 20705031238036: RELIEVA SCOUT MULTI-SINUS DILATION SYSTEM