Neo Delta Self Safe® - Neo Delta Self Safe 1 - DELTA MED SPA

Duns Number:444776777

Device Description: Neo Delta Self Safe 1

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More Product Details

Catalog Number

-

Brand Name

Neo Delta Self Safe®

Version/Model Number

3718122

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"

Yes

For Single-Use

Yes

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

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Device Record Status

Public Device Record Key

81f7349b-217b-4868-a658-78dbf1b31211

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

58032248371816

Quantity per Package

4

Contains DI Package

38032248371812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DELTA MED SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 105