Vista 6" Cotton tip Applicators - Vista Dental

Duns Number:036623932

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More Product Details

Catalog Number

-

Brand Name

Vista 6" Cotton tip Applicators

Version/Model Number

202006

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KXF

Product Code Name

Applicator, Absorbent Tipped, Non-Sterile

Device Record Status

Public Device Record Key

f5b6115f-669d-45ee-8c73-30d472c58bcd

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VISTA DENTAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 316
2 A medical device with a moderate to high risk that requires special controls. 144
U Unclassified 36