AccessGUDID - DEVICE: BioGreen (00856402006061)

GUDID

Device Identifier (DI) Information

Brand Name: BioGreen
Version or Model: 3005100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PREMIER DENTAL PRODUCTS COMPANY

Primary DI Number: 00856402006061
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 014789663 *Terms of Use

Device Description: BioGreen Micro-Applicator - Regular

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?
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXR	Applicator, Resin

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: c4a05a45-cfc4-4aff-9951-1734638fc4ee
Public Version Date: July 07, 2022
Public Version Number: 4
DI Record Publish Date: December 30, 2016