HEPRO.US Syringe with 3ml/cc 22G x 3/4 - 100/Box - Syringe with Attached Needle 3ml/cc 22G x 3/4 Box - HEPRO.US INC.

Duns Number:080061451

Device Description: Syringe with Attached Needle 3ml/cc 22G x 3/4 Box 100 units

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More Product Details

Catalog Number

-

Brand Name

HEPRO.US Syringe with 3ml/cc 22G x 3/4 - 100/Box

Version/Model Number

BX 3ml/cc 22G x 3/4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

-

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

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

7443ec49-6390-4f70-ba54-b0c43e582fb5

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

June 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEPRO.US INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 20