RELIEVA FLEX - RELIEVA FLEX SINUS GUIDE CATHETER M-110, 1 PK - ACCLARENT, INC.

Duns Number:361092450

Device Description: RELIEVA FLEX SINUS GUIDE CATHETER M-110, 1 PK

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More Product Details

Catalog Number

GC110RFZ

Brand Name

RELIEVA FLEX

Version/Model Number

GC110RFZ

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

KAM

Product Code Name

CANNULA, SINUS

Device Record Status

Public Device Record Key

9787b5dc-e6c1-4834-be79-7c1357c8bc4e

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

October 01, 2016

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