Applikator Fixation for Bougie D=10mm - Eckert & Ziegler BEBIG GmbH

Duns Number:331080432

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

LAZ01-10

Brand Name

Applikator Fixation for Bougie D=10mm

Version/Model Number

LAZ01-10#03

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

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

K142986

Product Code Details

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Device Record Status

Public Device Record Key

ec09ac30-181a-4a03-8b32-2fb9a562dec9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ECKERT & ZIEGLER BEBIG GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 221