AccessGUDID - DEVICE: Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/Tubing (B3901912038T1)

GUDID

Device Identifier (DI) Information

Brand Name: Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/Tubing
Version or Model: 19-12038T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SURETEK MEDICAL

Primary DI Number: B3901912038T1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785616934 *Terms of Use

Device Description: Reprocessed 4mm Endo-Scrub 2 Sheath, 0 deg, w/Tubing. Used with Olympus WA96200A

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?
44711	Optical medical device procedural cover	A device designed to fit over the distal end of a non-surgically-invasive device with optical functionality (e.g., laser beam-guide, optical scanning handpiece, endoscope) during use, to act as a cover/shield to avoid direct contact to the eye and/or cross-contamination between patients; it is not intended to act as a spacer. It is typically a small rigid partially- or fully- transparent plastic device. 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: 3eaf3681-3617-45de-892c-da0adedcd51f
Public Version Date: May 09, 2025
Public Version Number: 1
DI Record Publish Date: May 01, 2025