Catalog Number

SBN198

Brand Name

SafeSept Blunt Needle

Version/Model Number

SBN198

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K210328,K210328

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

b8146a89-9725-43e2-bff7-1e71b7316d0e

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 15, 2021

Package DI Number

30858769006402

Quantity per Package

5

Contains DI Package

00858769006401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box