AccessGUDID - DEVICE: Ansell Edmont (10618125189141)

GUDID

Device Identifier (DI) Information

Brand Name: Ansell Edmont
Version or Model: 9211-400AN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9211-400AN
Company Name: TIDI PRODUCTS, LLC

Primary DI Number: 10618125189141
Issuing Agency: GS1
Commercial Distribution End Date: February 13, 2025
Device Count: 100
Labeler D-U-N-S® Number*: 063519193 *Terms of Use

Device Description: Assemble 'n Go Eyewear Replacement Frames

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
58376	Eye splash shield, single-use	A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYU	Accessory, Surgical Apparel

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: 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: cbb9d1c4-da92-4924-bbbb-34cb4f10190f
Public Version Date: February 14, 2025
Public Version Number: 2
DI Record Publish Date: October 21, 2022