AccessGUDID - DEVICE: AMBITEX (00699320107911)

GUDID

Device Identifier (DI) Information

Brand Name: AMBITEX
Version or Model: LXS240
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LXS240
Company Name: Tradex Holdings LLC

Primary DI Number: 00699320107911
Issuing Agency: GS1
Commercial Distribution End Date: October 21, 2021
Device Count: 100
Labeler D-U-N-S® Number*: 118875127 *Terms of Use

Device Description: AMBITEX LATEX EXAM PF XS

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?
61631	Nitrile examination/treatment glove, non-powdered, sterile	A sterile device made of nitrile 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 patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	Obsolete	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: 4b256915-41fd-4e78-971c-38aab734d184
Public Version Date: January 18, 2024
Public Version Number: 4
DI Record Publish Date: April 05, 2019