T-Handle Cann Hud-Mod - T-Handle Cann Hud-Mod - SMV SCIENTIFIC LLC

Duns Number:089645059

Device Description: T-Handle Cann Hud-Mod

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More Product Details

Catalog Number

202-0802

Brand Name

T-Handle Cann Hud-Mod

Version/Model Number

202-0802

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

-

Product Code Details

Product Code

OUR

Product Code Name

Sacroiliac Joint Fixation

Device Record Status

Public Device Record Key

86b82473-a016-4ab7-bdeb-c3055e42ba35

Public Version Date

August 24, 2022

Public Version Number

1

DI Record Publish Date

August 16, 2022

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