Aztec - Webster Needle Holder, Tungsten Carbide Jaws - Aztecmed/Ent LLC

Duns Number:117559084

Device Description: Webster Needle Holder, Tungsten Carbide Jaws

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More Product Details

Catalog Number

10-21010

Brand Name

Aztec

Version/Model Number

10-21010

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

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Device Record Status

Public Device Record Key

da10c3b7-deb0-4d75-96f3-9e9010ddf3ef

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

October 06, 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