FLOWS-RITE - FLOWS-RITE A3.5 REFILL KIT 4 x 1.5 gm syringes + - PULPDENT CORPORATION

Duns Number:001006089

Device Description: FLOWS-RITE A3.5 REFILL KIT 4 x 1.5 gm syringes + 20 tips

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More Product Details

Catalog Number

-

Brand Name

FLOWS-RITE

Version/Model Number

FKA35

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

-

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

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

1af8c1b3-ab4c-46f5-a6ed-26ac83fc28a5

Public Version Date

December 02, 2019

Public Version Number

1

DI Record Publish Date

November 22, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PULPDENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 177