SparrowHawk - 5058 SparrowHawk Endomyocardial Biopsy Forceps, - ATC TECHNOLOGIES, INC.

Duns Number:023131605

Device Description: 5058 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 105cm, Straight, Disposable

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More Product Details

Catalog Number

-

Brand Name

SparrowHawk

Version/Model Number

5058

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

Yes

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

K010473,K010473

Product Code Details

Product Code

DWZ

Product Code Name

Device, Biopsy, Endomyocardial

Device Record Status

Public Device Record Key

81ba9d10-e783-47b0-9734-b88e4e2754d3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

00817428020615

Quantity per Package

5

Contains DI Package

00817428020608

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ATC TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 99