EUROPCLIP - Ultra D-Grip clip applier, straight,280 mm, for - Ackermann Instrumente GmbH

Duns Number:315121009

Device Description: Ultra D-Grip clip applier, straight,280 mm, for medium-large clips

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More Product Details

Catalog Number

AI-321542DD

Brand Name

EUROPCLIP

Version/Model Number

AI-321542DD

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

-

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

GDO

Product Code Name

Applier, Surgical, Clip

Device Record Status

Public Device Record Key

737b16b9-110d-4b14-8925-42e58633e417

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACKERMANN INSTRUMENTE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 80