AccessGUDID - DEVICE: HurriView II (00723797110515)

GUDID

Device Identifier (DI) Information

Brand Name: HurriView II
Version or Model: base unit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BEUTLICH PHARMACEUTICALS, LLC

Primary DI Number: 00723797110515
Issuing Agency: GS1
Commercial Distribution End Date: December 03, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 005209325 *Terms of Use

Device Description: Two-Tone Dental Plaque Disclosing Liquid; swab, each

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?
60408	Dental caries detecting stain	A liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJC	Plaque Disclosing Agent

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c6f0689e-87d8-4a0b-b1a6-92e5fa3b1175
Public Version Date: January 08, 2020
Public Version Number: 4
DI Record Publish Date: October 01, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
02723797110575	24	01723797110576	2019-12-03	Not in Commercial Distribution	shipper
01723797110576	72	00723797110515	2019-12-03	Not in Commercial Distribution	box