AccessGUDID - DEVICE: Two DX 1.5+ Holders + Two G-Rings and Rods (00856200001206)

GUDID

Device Identifier (DI) Information

Brand Name: Two DX 1.5+ Holders + Two G-Rings and Rods
Version or Model: 001-206
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001-206
Company Name: CLIKTECH LLC

Primary DI Number: 00856200001206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044516217 *Terms of Use

Device Description: Two DX 1.5+ Holders + Two G-Rings and Rods

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):	No
Over the Counter (OTC):	Yes
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?
16205	Dental x-ray film holder, reusable	A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGZ	Holder, Film, X-Ray

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: c4c9e467-e9ba-4fba-bd7a-a3b21832ec09
Public Version Date: January 08, 2021
Public Version Number: 1
DI Record Publish Date: December 31, 2020