AccessGUDID - DEVICE: Essentials by 3D Dental (00817169029175)

GUDID

Device Identifier (DI) Information

Brand Name: Essentials by 3D Dental
Version or Model: AWNCW-250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AWNCW-250
Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Primary DI Number: 00817169029175
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080194935 *Terms of Use

Device Description: ESSENTIALS PLASTIC NO CORE WHITE TIPS 250/BAG *SPREE TIP STYLE**

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:	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?
62258	Oral/enteral syringe drawing-up straw	A flexible, blunt, tubular device intended to be connected to an oral/enteral syringe for the convenient transfer of fluids (e.g., dissolved medication, liquid nutrition) from an open container into the syringe prior to oral/enteral administration; it is not intended to puncture the seal of a vial/container, nor is it intended for patient contact. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECB	Unit, Syringe, Air And/Or Water

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: a6ae32b0-ec82-4578-8078-339b3facaa58
Public Version Date: December 26, 2022
Public Version Number: 1
DI Record Publish Date: December 16, 2022