AccessGUDID - DEVICE: Darby Dental Supply, LLC (00889813009284)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: 9512779
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9512779
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 00889813009284
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: REAMER 21MM #15 SILICONE STOP DARBY

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?
31875	Endodontic reamer	A hand-held dental instrument used with a rotary action and designed to debride or enlarge the root canal by a side cutting action. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EKP	REAMER, PULP CANAL, ENDODONTIC

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: 66ca6db7-f479-4ac8-b093-ac414af38300
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 22, 2017