LAZIC - STORAGE TRAY FOR 134 D-ANEURYSM-CLIPS AND - Peter Lazic GmbH

Duns Number:327681359

Device Description: STORAGE TRAY FOR 134 D-ANEURYSM-CLIPS AND CLIP-APPLIERS / INSTRUMENTS, ALU-CASE WITH 5 PPS STORAGE TRAY FOR 134 D-ANEURYSM-CLIPS AND CLIP-APPLIERS / INSTRUMENTS, ALU-CASE WITH 5 PPSU BOXES FOR CLIPS 540x253x95 MM

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More Product Details

Catalog Number

35.028

Brand Name

LAZIC

Version/Model Number

35.028

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

LRP

Product Code Name

Tray, Surgical

Device Record Status

Public Device Record Key

028d8c25-f004-4841-a313-7583ae191040

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PETER LAZIC GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1084
2 A medical device with a moderate to high risk that requires special controls. 1125