AccessGUDID - DEVICE: RELIEVA SPINPLUS NAV (10705031241015)

GUDID

Device Identifier (DI) Information

Brand Name: RELIEVA SPINPLUS NAV
Version or Model: RSP0616MFSN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSP0616MFSN
Company Name: ACCLARENT, INC.

Primary DI Number: 10705031241015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 361092450 *Terms of Use

Device Description: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48140	Nasal/paranasal balloon catheter	A sterile flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to temporarily relieve nasal obstruction/congestion. The device typically consists of a single-lumen tube with a connector at the proximal end for attachment to an inflation device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL SURGICAL
PGW	Ear, Nose, and Throat Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171687	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14b54b4a-21bd-4a45-b9ef-87c843264ba0
Public Version Date: November 21, 2024
Public Version Number: 8
DI Record Publish Date: February 18, 2018