AccessGUDID - DEVICE: KROMALGIN Piu 300x18g (00803371256102)

GUDID

Device Identifier (DI) Information

Brand Name: KROMALGIN Piu 300x18g
Version or Model: 002003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 002003
Company Name: VANNINI DENTAL INDUSTRY SRL

Primary DI Number: 00803371256102
Issuing Agency: GS1
Commercial Distribution End Date: July 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 436650394 *Terms of Use

Device Description: Alginate for dental impressions

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	No
Combination Product:	Yes
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?
35863	Alginate dental impression material	A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is 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 [?]
K963609	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: Handling Environment Temperature
Storage Environment Temperature: between 4 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 27280 Milliliter

Device Record Status

Public Device Record Key: 25ff8c8e-e8ef-4b1c-b507-304069dd1b9e
Public Version Date: July 31, 2020
Public Version Number: 2
DI Record Publish Date: July 31, 2019