Sydney IVF - SYDNEY IVF, HYALURONIDASE - WILLIAM A. COOK AUSTRALIA PTY. LTD.

Duns Number:758568000

Device Description: SYDNEY IVF, HYALURONIDASE

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More Product Details

Catalog Number

K-SIHY-1-5-AA

Brand Name

Sydney IVF

Version/Model Number

G46304

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

K151367

Product Code Details

Product Code

MQL

Product Code Name

MEDIA, REPRODUCTIVE

Device Record Status

Public Device Record Key

ec8f470e-a7c9-4508-b7cd-20e3af68220b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 15, 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