RODIN - CTL MEDICAL CORPORATION

Duns Number:080138504

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More Product Details

Catalog Number

-

Brand Name

RODIN

Version/Model Number

S.027.1021

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

K160646

Product Code Details

Product Code

MQP

Product Code Name

Spinal vertebral body replacement device

Device Record Status

Public Device Record Key

e4dcb093-42ef-48fb-baf6-938ab575a2b2

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

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