AccessGUDID - DEVICE: RELIEVA SPINPLUS NAV (20705031245430)

GUDID

Device Identifier (DI) Information

Brand Name: RELIEVA SPINPLUS NAV
Version or Model: RSP0616MFSNZ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSP0616MFSNZ
Company Name: ACCLARENT, INC.

Primary DI Number: 20705031245430
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 - 1PK

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

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: 2df4ced3-16be-48f4-aa78-71b2fc4ab31a
Public Version Date: November 21, 2024
Public Version Number: 8
DI Record Publish Date: February 18, 2018