GM501 Gradient 100% - GM501 Gradient 100% is a stock solution for semen - HAMILTON THORNE, INC.

Duns Number:152161337

Device Description: GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isoton GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.

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More Product Details

Catalog Number

-

Brand Name

GM501 Gradient 100%

Version/Model Number

4GM501G-100-500

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

6e8977a6-4771-471c-900b-5bfa52fda25d

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