RELIEVA SPINPLUS NAV RSP0616MFSNZ

GUDID 20705031245430

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

ACCLARENT, INC.

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
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com

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.
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	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