Nyclave Tubing 3" X 100' - Sterilization tubing - YOUNG DENTAL MANUFACTURING I, LLC

Duns Number:006309355

Device Description: Sterilization tubing

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More Product Details

Catalog Number

-

Brand Name

Nyclave Tubing 3" X 100'

Version/Model Number

112310

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)

-

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

522c2872-6210-4bcc-a3f0-39df1e4a24aa

Public Version Date

October 05, 2022

Public Version Number

7

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20302731123107

Quantity per Package

72

Contains DI Package

10302731123100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipping box

"YOUNG DENTAL MANUFACTURING I, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 138
2 A medical device with a moderate to high risk that requires special controls. 85