QUALA - QUALA SCISSORS-CROWN/GOLD CRVD SMTH 4.5 - NATIONAL DISTRIBUTION & CONTRACTING, INC.

Duns Number:009831413

Device Description: QUALA SCISSORS-CROWN/GOLD CRVD SMTH 4.5

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More Product Details

Catalog Number

QSCGC

Brand Name

QUALA

Version/Model Number

QSCGC

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

EGN

Product Code Name

Scissors, Surgical Tissue, Dental

Device Record Status

Public Device Record Key

aea5dd95-0ce4-44a4-8aa5-9ffda0084173

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATIONAL DISTRIBUTION & CONTRACTING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 224
2 A medical device with a moderate to high risk that requires special controls. 192