AccessGUDID - DEVICE: Plastic for Closed Tray Transfer for Multi-Unit (07290112444356)

GUDID

Device Identifier (DI) Information

Brand Name: Plastic for Closed Tray Transfer for Multi-Unit
Version or Model: EI-4765
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ETGAR - MEDICAL INSTRUMENTS LTD

Primary DI Number: 07290112444356
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514570324 *Terms of Use

Device Description: Plastic for Closed Tray Transfer for Multi-Unit

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
Prescription Use (Rx):	No
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?
34799	Composite dental impression material	A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

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: 3b9f1e79-c3da-4abf-a90b-efc24f1af3e1
Public Version Date: April 04, 2018
Public Version Number: 1
DI Record Publish Date: March 04, 2018