AccessGUDID - DEVICE: Yates Motloid Coldpac Denture and Repair Acrylic (00706069343163)

GUDID

Device Identifier (DI) Information

Brand Name: Yates Motloid Coldpac Denture and Repair Acrylic
Version or Model: DK1601
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIRD-X, INC.

Primary DI Number: 00706069343163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025055773 *Terms of Use

Device Description: Coldpac Denture and Repair Acrylic Kit. Contains one 16 oz. powder (Light Fibered) and one 8 oz. liquid.

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
16730	Dental appliance fabrication material, resin	A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	Resin, Denture, Relining, Repairing, Rebasing

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
Storage Environment Temperature: less than 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 1 Pound
Total Volume: 8.0 Fluid Ounce

Device Record Status

Public Device Record Key: 7881f553-ac93-4685-b68d-ee2d0ca69e99
Public Version Date: November 10, 2021
Public Version Number: 4
DI Record Publish Date: August 26, 2016