PERIO-X ELITE DENTAL FLOSS - MAXILL, INC.

Duns Number:079343581

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More Product Details

Catalog Number

-

Brand Name

PERIO-X ELITE DENTAL FLOSS

Version/Model Number

6070541113

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

JES

Product Code Name

Floss, Dental

Device Record Status

Public Device Record Key

43e9f022-5331-4fe7-aa70-42a01f78730e

Public Version Date

September 15, 2022

Public Version Number

1

DI Record Publish Date

September 07, 2022

Additional Identifiers

Package DI Number

D89260705411131

Quantity per Package

6

Contains DI Package

D89260705411130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag

"MAXILL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208
2 A medical device with a moderate to high risk that requires special controls. 61