Stellar Medical - 1, 18 ga x 12cm needle containing 1, 1.0 x 3mm - STELLAR MEDICAL, LLC

Duns Number:015116092

Device Description: 1, 18 ga x 12cm needle containing 1, 1.0 x 3mm gold marker, St

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More Product Details

Catalog Number

-

Brand Name

Stellar Medical

Version/Model Number

103112SM

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092041

Product Code Details

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Device Record Status

Public Device Record Key

e4cc8fc0-7994-494a-ba8c-6e97c8666e6b

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STELLAR MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 60