12ml Syringe - 12 ml syringe. Double aseptically pouched. 12 - ORIGEN BIOMEDICAL, INC.

Duns Number:625272232

Device Description: 12 ml syringe. Double aseptically pouched. 12 per case

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More Product Details

Catalog Number

-

Brand Name

12ml Syringe

Version/Model Number

R12-C

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

-

Product Code Details

Product Code

KJG

Product Code Name

Tube, Tissue Culture

Device Record Status

Public Device Record Key

6b7a6eff-066d-4878-ba83-d6b2365d813e

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20816203021889

Quantity per Package

12

Contains DI Package

10816203021882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ORIGEN BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 18
U Unclassified 44