6.0 x 110mm Screw Fastener ST - 6.0 x 110mm Screw Fastener ST - SMV SCIENTIFIC LLC

Duns Number:089645059

Device Description: 6.0 x 110mm Screw Fastener ST

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More Product Details

Catalog Number

360-1110

Brand Name

6.0 x 110mm Screw Fastener ST

Version/Model Number

360-1110

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

K210247

Product Code Details

Product Code

JDO

Product Code Name

Device, Fixation, Proximal Femoral, Implant

Device Record Status

Public Device Record Key

cf1058c5-b6c1-4cb7-8410-4524fd058d76

Public Version Date

May 14, 2021

Public Version Number

1

DI Record Publish Date

May 06, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMV SCIENTIFIC LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 60
2 A medical device with a moderate to high risk that requires special controls. 846