NOBIL METAL SPA - LV KON KIT FOR DIRECT MODELLING - NOBIL METAL SPA

Duns Number:436857494

Device Description: LV KON KIT FOR DIRECT MODELLING

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More Product Details

Catalog Number

KN-802-W

Brand Name

NOBIL METAL SPA

Version/Model Number

LV KON

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

-

Product Code Details

Product Code

EJX

Product Code Name

Anchor, Preformed

Device Record Status

Public Device Record Key

e81b1bd7-586f-4db2-a0d4-1fe6d279eeb7

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOBIL METAL SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9