iLumi - 10 Super Fiber Posts (serrated) 1.35 mm. - Ilumi Sciences, Inc.

Duns Number:058316335

Device Description: 10 Super Fiber Posts (serrated) 1.35 mm.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

iLumi

Version/Model Number

SR-9135

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

ELR

Product Code Name

Post, Root Canal

Device Record Status

Public Device Record Key

f658f55d-22c4-476d-8323-cec6108e4008

Public Version Date

May 31, 2022

Public Version Number

1

DI Record Publish Date

May 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ILUMI SCIENCES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31