Starr Frame Half Pin - Starr Frame Half Pin, 375 mm6mm, 375 x 70mm1 each - STARR FRAME LLC

Duns Number:804185838

Device Description: Starr Frame Half Pin, 375 mm6mm, 375 x 70mm1 each

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More Product Details

Catalog Number

SF-2375-6071

Brand Name

Starr Frame Half Pin

Version/Model Number

SF-2375-6071

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

K082017,K082017

Product Code Details

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Device Record Status

Public Device Record Key

e615bd62-0d54-4561-9ff3-90335eff461f

Public Version Date

September 22, 2020

Public Version Number

1

DI Record Publish Date

September 14, 2020

Additional Identifiers

Package DI Number

00854226007134

Quantity per Package

10

Contains DI Package

00854226007127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf carton

"STARR FRAME LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 3