AccessGUDID - DEVICE: Stradis Medical, LLC (M752EAM5004FB0)

GUDID

Device Identifier (DI) Information

Brand Name: Stradis Medical, LLC
Version or Model: EA-M5004FB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STRADIS MEDICAL, LLC

Primary DI Number: M752EAM5004FB0
Issuing Agency: HIBCC
Commercial Distribution End Date: February 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 174262477 *Terms of Use

Device Description: 4% CHG Skin Cleansing Kit

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
35246	Surgical patient preparation kit	A collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 5161dd27-3d3a-4a50-af65-4099f5bed94f
Public Version Date: February 07, 2023
Public Version Number: 3
DI Record Publish Date: December 12, 2018