AccessGUDID - DEVICE: HurriSeal Dentin Desensitizer 12mL (01723797697824)

GUDID

Device Identifier (DI) Information

Brand Name: HurriSeal Dentin Desensitizer 12mL
Version or Model: 12mL bottle
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BEUTLICH PHARMACEUTICALS, LLC

Primary DI Number: 01723797697824
Issuing Agency: GS1
Commercial Distribution End Date: November 04, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 005209325 *Terms of Use

Device Description: 12mL bottle - dentin desensitizing liquid formula.

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?
64794	Dental coating, tooth-desensitizing, professional	A substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	Agent, Tooth Bonding, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973002	000

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
Special Storage Condition, Specify: Do not freeze.
Special Storage Condition, Specify: Refrigerate if not used for long periods of time.
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a63df029-6baf-430f-8df1-2a3d3ad57fed
Public Version Date: November 05, 2020
Public Version Number: 6
DI Record Publish Date: October 01, 2016