AccessGUDID - DEVICE: Gishy Goo (00883205107312)

GUDID

Device Identifier (DI) Information

Brand Name: Gishy Goo
Version or Model: 500059
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500059
Company Name: ULTRADENT PRODUCTS, INC.

Primary DI Number: 00883205107312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013369913 *Terms of Use

Device Description: Gishy Goo! Syringe, Tooth Color 10-Pack

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):	No
Over the Counter (OTC):	Yes
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?
41678	Orthodontic appliance system, bonded	An assembly of custom-made and preformed devices such as metal bands, archwires, springs, screws, power arms and/or a base plate (framework), designed to be applied to the teeth to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Often referred to as dental braces, it is intended to remain in the oral cavity for the duration of the treatment, and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EGD	WAX, DENTAL, INTRAORAL

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 18 and 29 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a96996cf-8a4f-4696-889d-0a3cb0a79156
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: June 16, 2018

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(801)572-4200
Email: customerservice@ultradent.com

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