RELIEVA SPINPLUS NAV RSP0616MFSNZ

GUDID 20705031245430

RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT - 1PK

ACCLARENT, INC.

Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter

• Primary Device ID: 20705031245430
• NIH Device Record Key: 2df4ced3-16be-48f4-aa78-71b2fc4ab31a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIEVA SPINPLUS NAV
• Version Model Number: RSP0616MFSNZ
• Catalog Number: RSP0616MFSNZ
• Company DUNS: 361092450
• Company Name: ACCLARENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: xxx@xxx.xxx
• Phone: +1(877)775-2789
• Email: xxx@xxx.xxx

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705031245430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171687

FDA Product Code

• PGW: Ear, Nose, and Throat Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-22
• Device Publish Date: 2018-02-18

On-Brand Devices [RELIEVA SPINPLUS NAV]

• 20705031245430: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT - 1PK
• 20705031245423: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 5X16MM, 3 GUIDE KIT - 1PK
• 20705031241012: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
• 20705031241005: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 5X16MM, 3 GUIDE KIT