Ultrapak - Ultrapak Cord #2 - ULTRADENT PRODUCTS, INC.

Duns Number:013369913

Device Description: Ultrapak Cord #2

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More Product Details

Catalog Number

133

Brand Name

Ultrapak

Version/Model Number

133

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

-

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

JES

Product Code Name

FLOSS, DENTAL

Device Record Status

Public Device Record Key

bf236c00-b4a2-4545-bae7-45a9194a8270

Public Version Date

May 29, 2018

Public Version Number

1

DI Record Publish Date

April 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ULTRADENT PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 450
2 A medical device with a moderate to high risk that requires special controls. 631
U Unclassified 18