AccessGUDID - DEVICE: E-Z ID Tape (00840161305671)

GUDID

Device Identifier (DI) Information

Brand Name: E-Z ID Tape
Version or Model: 70Z310
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ZIRC DENTAL PRODUCTS, INC.

Primary DI Number: 00840161305671
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 064783913 *Terms of Use

Device Description: Declassified as non-medical device. "EZ-ID Tape System Vibrant, System comes with eight 3 ft. rolls of tape and a rack that holds them organized and accessible for use 1x3ft rolls of Neon Blue 1x3ft rolls of Neon Yellow 1x3ft roll of Neon Green 1x3ft roll of Neon Orange 2x3ft roll of Neon Purple 2x3ft roll of Neon Pink"

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:	No
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?
47825	Surgical instrument track identification tape	A non-sterile, colour-coded, band coated on one side with a pressure-sensitive adhesive intended to attach to a surgical instrument; it is typically wrapped around the handle or shaft to indicate instrument ownership (e.g., by doctor, hospital floor, department or ward) and identifies the instrument prior to and during a surgical procedure. This marking will facilitate that the correct instruments are returned to the correct owner particularly after being sterilized in the hospital sterilization department or other facility. It is typically made of plastic material and is available in a sheet with different size strips of tape or in continuous roll (a spool). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYV	Label Or Tag, Sterile

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
Length: 91.4 Centimeter

Device Record Status

Public Device Record Key: 4ee60ddc-c8e2-4ca5-b153-f040ca8b1f34
Public Version Date: March 10, 2025
Public Version Number: 2
DI Record Publish Date: October 25, 2022