AccessGUDID - DEVICE: everStick® (J0229008271)

GUDID

Device Identifier (DI) Information

Brand Name: everStick®
Version or Model: 900827
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 900827
Company Name: Gc America Inc.

Primary DI Number: J0229008271
Issuing Agency: HIBCC
Commercial Distribution End Date: October 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: everStick® POST Intro Kit (5 x 0.9 posts, 5 x 1.2 posts and 5 x 1.5 posts and 1 x 5 mL of StickRESIN bottle)

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?
38610	Root canal post, custom-made	An endodontic rod designed for insertion into the root canal of a specific patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it may, however, be created in/from a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELR	POST, ROOT CANAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030820	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 35 and 46 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: acbcb257-beba-47ab-a19b-2e0b3796cb85
Public Version Date: October 01, 2021
Public Version Number: 6
DI Record Publish Date: August 01, 2016