MONET - CTL MEDICAL CORPORATION

Duns Number:080138504

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More Product Details

Catalog Number

-

Brand Name

MONET

Version/Model Number

113.5311

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

K172788

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Device Record Status

Public Device Record Key

a96267b3-15c5-487c-91bc-85808c965eb7

Public Version Date

November 05, 2019

Public Version Number

1

DI Record Publish Date

October 28, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CTL MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 541
2 A medical device with a moderate to high risk that requires special controls. 1990