SAGE 1-Step - SAGE 1-Step GM-CSF with SPS. 3 ml. - Origio A/S

Duns Number:305424269

Device Description: SAGE 1-Step GM-CSF with SPS. 3 ml.

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More Product Details

Catalog Number

-

Brand Name

SAGE 1-Step

Version/Model Number

77020003D

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

-

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

K172197

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

e3aa6120-f9df-48fd-a70b-dbac4e53f73a

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORIGIO A/S" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 93