AOS Implant Tube, Breast/Head/Neck, Puthawala/Syed - Implant Tube, Breast/Head/Neck, Puthawala/Syed, - ALPHA-OMEGA SERVICES, INC.

Duns Number:060398989

Device Description: Implant Tube, Breast/Head/Neck, Puthawala/Syed, 28 cm Leader, 25 cm Body, with Female Luer Implant Tube, Breast/Head/Neck, Puthawala/Syed, 28 cm Leader, 25 cm Body, with Female Luer Adaptor, Cable Insert, with Green Nylon Retaining Buttons and Stainless Steel Retaining Buttons, 20 ea

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More Product Details

Catalog Number

-

Brand Name

AOS Implant Tube, Breast/Head/Neck, Puthawala/Syed

Version/Model Number

TIB0001-003

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

fd36ec78-45ad-42fb-a7a8-42736aa1ad90

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 05, 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