AccessGUDID - DEVICE: Evolve by 3D Dental (00817169028888)

GUDID

Device Identifier (DI) Information

Brand Name: Evolve by 3D Dental
Version or Model: EVALUR5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EVALUR5
Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Primary DI Number: 00817169028888
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080194935 *Terms of Use

Device Description: Evolve Stainless Steel Primary Anterior Lateral Upper Right #5 Crowns Box Of 5

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):	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?
34979	Rigid optical culdoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the female peritoneal cavity and organs. It is inserted into the body through a small incision made in the posterior vaginal fornix into the cul-de-sac, also called the rectouterine pouch (pouch of Douglas), during culdoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is used to examine structures of the uterus, ovaries, fallopian tubes, pelvis, and pelvic cavity when the physician is viewing the area from just behind the uterus. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELZ	Crown, Preformed

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: 6e922c2e-ca09-40c7-afd1-49a199682b69
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: December 28, 2022