AccessGUDID - DEVICE: Darby Dental Supply, LLC (00889813020647)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: 9519063
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9519063
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 00889813020647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: Etch Gel 12ml with tips

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:	Yes
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?
62474	Dental prosthesis priming agent	A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	AGENT, TOOTH BONDING, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51a8935d-e5d8-493c-8f58-711562ae2a8d
Public Version Date: October 01, 2018
Public Version Number: 1
DI Record Publish Date: August 31, 2018