AccessGUDID - DEVICE: Acu-Flow™ Putty Kit (07540172018784)

GUDID

Device Identifier (DI) Information

Brand Name: Acu-Flow™ Putty Kit
Version or Model: 1-016405
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1-016405
Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Primary DI Number: 07540172018784
Issuing Agency: GS1
Commercial Distribution End Date: November 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 626406016 *Terms of Use

Device Description: Hydrophillic Impression Material

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):	No
Kit:	Yes
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?
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELW	MATERIAL, IMPRESSION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053018	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
Storage Environment Temperature: between 17 and 24 Degrees Celsius
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2 x 300mL Jar
Total Volume: 600 Milliliter

Device Record Status

Public Device Record Key: ef0dfdb3-85df-4de5-8c19-32aa9f465b7f
Public Version Date: November 02, 2022
Public Version Number: 2
DI Record Publish Date: July 27, 2021