AccessGUDID - DEVICE: Darby Dental Supply, LLC (00889813044087)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: 9523552
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9523552
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 00889813044087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: S/T 40M LATCH BB C/A HEAD

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?
66244	Dental surgical power tool motorized handpiece/set, pneumatic	A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes a pneumatic motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGS	Handpiece, contra- and right-angle attachment, dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073652	000

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: fdee2a6c-9b1e-4b57-9236-09469c0bb31a
Public Version Date: August 08, 2022
Public Version Number: 1
DI Record Publish Date: July 29, 2022