AccessGUDID - DEVICE: Darby Dental Supply, LLC (00889813059258)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: 5254470
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5254470
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 00889813059258
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: HEMOSTATIC GAUZE DRESSING

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?
63636	General oral wound dressing, non-animal-derived, sterile	A sterile device intended to be used as a protective cover for the general oral mucosa to treat surgical or traumatic wounds/lesions in the mouth. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home or a clinical setting. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MGQ	Dressing, wound and burn, hydrogel w/drug and/or biologic

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation 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: 672687b9-25d6-4ca9-a26c-3451f0b35976
Public Version Date: November 08, 2022
Public Version Number: 1
DI Record Publish Date: October 31, 2022