Shaver System Irrigation Clips - The Shaver System Irrigation Clips are an - ENTELLUS MEDICAL, INC.

Duns Number:017283879

Device Description: The Shaver System Irrigation Clips are an accessory to the Shaver System Irrigation Stand. The Shaver System Irrigation Clips are an accessory to the Shaver System Irrigation Stand. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

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More Product Details

Catalog Number

-

Brand Name

Shaver System Irrigation Clips

Version/Model Number

SSA-106

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

GBX

Product Code Name

Catheter, Irrigation

Device Record Status

Public Device Record Key

9f97ace4-d40d-4621-a3df-e083dfba85d2

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENTELLUS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 27