Crystal Tip - CRYSTAL HP BULK MARINE GREEN, TIPS - Young Innovations, Inc.

Duns Number:004193103

Device Description: CRYSTAL HP BULK MARINE GREEN, TIPS

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More Product Details

Catalog Number

CT2203

Brand Name

Crystal Tip

Version/Model Number

CT2203

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

ECB

Product Code Name

UNIT, SYRINGE, AIR AND/OR WATER

Device Record Status

Public Device Record Key

4eb77094-60ed-43ea-8a98-1fc140a1679e

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 23, 2022

Additional Identifiers

Package DI Number

10843471132736

Quantity per Package

1500

Contains DI Package

00843471132739

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package

"YOUNG INNOVATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 77
2 A medical device with a moderate to high risk that requires special controls. 38