Cook - Ovum Aspiration Needle, Single Lumen - WILLIAM A. COOK AUSTRALIA PTY. LTD.

Duns Number:758568000

Device Description: Ovum Aspiration Needle, Single Lumen

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More Product Details

Catalog Number

K-OPS-1630-H-B-90

Brand Name

Cook

Version/Model Number

G55481

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

K983593

Product Code Details

Product Code

MQE

Product Code Name

NEEDLE, ASSISTED REPRODUCTION

Device Record Status

Public Device Record Key

38400021-7ad3-4179-87af-a0f84bc3bc78

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WILLIAM A. COOK AUSTRALIA PTY. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 106
3 A medical device with high risk that requires premarket approval 93