Aztec - Klinik Operating Scissor curved - Aztecmed/Ent LLC

Duns Number:117559084

Device Description: Klinik Operating Scissor curved

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More Product Details

Catalog Number

11-24202

Brand Name

Aztec

Version/Model Number

11-24202

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

-

Product Code Details

Product Code

LRW

Product Code Name

Scissors, General, Surgical

Device Record Status

Public Device Record Key

5ef5c09d-5966-4fdc-bac6-36976413a3b3

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

October 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AZTECMED/ENT LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 189