AccessGUDID - DEVICE: HurriSeal Dentin Desensitizer Snap-N-Go Swab (00723797697115)

GUDID

Device Identifier (DI) Information

Brand Name: HurriSeal Dentin Desensitizer Snap-N-Go Swab
Version or Model: Snap-N-Go Swab
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BEUTLICH PHARMACEUTICALS, LLC

Primary DI Number: 00723797697115
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005209325 *Terms of Use

Device Description: Single swab applicator - 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:	Yes
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: Refrigerate if not used for long periods of time.
Special Storage Condition, Specify: Do not freeze.
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e139c151-5199-43f9-914e-13b28cb3f8ad
Public Version Date: July 17, 2023
Public Version Number: 8
DI Record Publish Date: October 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
02723797697113	3000	00723797697115	2021-04-30	Not in Commercial Distribution	3000 count bulk case
02723797697588	156	01723797697589	2021-04-30	Not in Commercial Distribution	case of 156 12 count
01723797697589	12	00723797697115	2021-04-30	Not in Commercial Distribution	12 count clamshell
01723797697114	2	00723797697115	2021-04-30	Not in Commercial Distribution	2 count box
01723797697473	36	00723797697115	2021-04-30	Not in Commercial Distribution	36 count box
10723797697587	12	00723797697115		In Commercial Distribution	12 count clamshell
20723797697584	156	10723797697587		In Commercial Distribution	Case of 156
10723797697471	36	00723797697115		In Commercial Distribution	36 count box
20723797697119	2	00723797697115		In Commercial Distribution	2 count box