AccessGUDID - DEVICE: Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing (B390191200T1)

GUDID

Device Identifier (DI) Information

Brand Name: Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing
Version or Model: 191200T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SURETEK MEDICAL

Primary DI Number: B390191200T1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785616934 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
48141	Paranasal sinus irrigation catheter	A sterile flexible tube designed to introduce fluid (e.g., saline solution) into the sinus cavities to provide irrigation for the flushing and removal of mucus, pus, and blood from the site of intervention. It typically consists of a single-lumen tube with end and/or side holes at the distal end; the proximal end is typically connected to a syringe or irrigation fluid pumping system via a Luer-lock. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAM	Cannula, Sinus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c09708a-545b-4b2a-89c1-9eefac9af1a4
Public Version Date: June 23, 2021
Public Version Number: 1
DI Record Publish Date: June 15, 2021