AccessGUDID - DEVICE: AMBITEX (00699320102015)

GUDID

Device Identifier (DI) Information

Brand Name: AMBITEX
Version or Model: LXS200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LXS200
Company Name: Cardinal Health 200, LLC

Primary DI Number: 00699320102015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: AMBITEX GLV EXAM NON-STERILE LATEX L200 CREAM POWDER-FREE EXTRA SMALL FULL TEXTURED STANDARD LENGTH 10/100

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
47172	Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial	A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYY	Latex patient examination glove

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051404	000
K093375	000

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: ea50761f-6254-4805-9b89-34429dd36438
Public Version Date: September 03, 2020
Public Version Number: 3
DI Record Publish Date: February 18, 2019