AccessGUDID - DEVICE: NATURE-CRYL® (D6583498311)

GUDID

Device Identifier (DI) Information

Brand Name: NATURE-CRYL®
Version or Model: 349831
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 349831
Company Name: Gc America Inc.

Primary DI Number: D6583498311
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: NATURE-CRYL® POUR 300mL 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:	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?
16729	Denture base resin, heat-cured	A resin that requires heat for polymerization intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually consists of an acrylic monomer of methyl methacrylate (typically supplied as a powder) that becomes a polymer (polymethylmethacrylate or PMMA) when mixed with a catalyst such as benzoylperoxide (typically supplied as a liquid). Reinforcing fillers may be included in the resin to increase its strength and/or durability. This is a single-use device.	Obsolete	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: between 60 and 80 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 300 Milliliter

Device Record Status

Public Device Record Key: 7f1d3868-9986-450b-b192-ae07a33fc500
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 01, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(708)597-0900
Email: customerservice@gcamerica.com

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