AccessGUDID - DEVICE: Darby Dental Supply, LLC (10889813001377)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: D101A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9508272
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 10889813001377
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: TRAY SLEEVES 11.5" X 16"

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?
47782	Patient surgical drape, single-use, non-sterile	A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PEM	Dental barriers and sleeves

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: 1cfcdd06-f488-4f08-b221-4e4ffc49bddc
Public Version Date: November 08, 2018
Public Version Number: 3
DI Record Publish Date: June 24, 2016