IEC-Innoview GmbH - 5 mm, 0 deg Laparoscope, L=300 mm, autoclavable, - INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.

Duns Number:010741028

Device Description: 5 mm, 0 deg Laparoscope, L=300 mm, autoclavable, Large View

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More Product Details

Catalog Number

30-0494-00

Brand Name

IEC-Innoview GmbH

Version/Model Number

30-0494-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K982276

Product Code Details

Product Code

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Device Record Status

Public Device Record Key

c74f7353-1084-4aa2-851e-3377a04edd4c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 24