AccessGUDID - DEVICE: Darby Dental Supply, LLC (10889813000974)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: FP-DARBY-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9509119
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 10889813000974
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: COMPOLITE BOND SE UNIT DOSE 0.125ML

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):	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?
42483	Dentine adhesive	A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.	Obsolete	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
Special Storage Condition, Specify: Do Not Freeze
Storage Environment Temperature: between 59 and 75 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.125 Milliliter

Device Record Status

Public Device Record Key: 154674b5-dacd-43d0-b1a9-4a2fdb40dc37
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 25, 2016