RELIEVA LUMA - RELIEVA LUMA LIGHT GUIDE CABLE ADAPTER - WOLF / - ACCLARENT, INC.

Duns Number:361092450

Device Description: RELIEVA LUMA LIGHT GUIDE CABLE ADAPTER - WOLF / DYONICS

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


More Product Details

Catalog Number

SISLGCAWOLF

Brand Name

RELIEVA LUMA

Version/Model Number

SISLGCAWOLF

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

-

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

EQH

Product Code Name

SOURCE, CARRIER, FIBEROPTIC LIGHT

Device Record Status

Public Device Record Key

86aa68ac-f01f-4763-8a88-14d4d69f1504

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCLARENT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 83
2 A medical device with a moderate to high risk that requires special controls. 43