GM501 Gradient 45% - GM501 Gradient 45% is a ready-to-use gradient - HAMILTON THORNE, INC.

Duns Number:152161337

Device Description: GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.

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More Product Details

Catalog Number

-

Brand Name

GM501 Gradient 45%

Version/Model Number

4GM501GR-45-10

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)

Yes

FDA Premarket Submission

K053494

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

0208de34-1c01-44ee-a3f1-0df4544d0c5d

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

April 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HAMILTON THORNE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 53