AOS Extension Adaptor - Set, Extension Adaptor for Stainless Steel - ALPHA-OMEGA SERVICES, INC.

Duns Number:060398989

Device Description: Set, Extension Adaptor for Stainless Steel Needles with Threaded Female Hubs, Numbered, Se Set, Extension Adaptor for Stainless Steel Needles with Threaded Female Hubs, Numbered, Series-17, 16 cm, Set of 15

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More Product Details

Catalog Number

-

Brand Name

AOS Extension Adaptor

Version/Model Number

SAE0001-015

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

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Device Record Status

Public Device Record Key

33978201-c469-4c65-8563-c5f6d971f941

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

October 04, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPHA-OMEGA SERVICES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16