AccessGUDID - DEVICE: Darby Dental Supply, LLC (00889813062142)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: 9501460
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 00889813062142
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 144
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: ARTICULATING PAPER THIN RD/BL

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?
16181	Dental articulation paper	A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFH	PAPER, ARTICULATION

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: 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: 86fe8f57-df72-4ee4-8188-de966d9a53bf
Public Version Date: September 25, 2024
Public Version Number: 1
DI Record Publish Date: September 17, 2024