Eigr™ Saber Waveguide - Intended to deliver illumination from a high - INVUITY, INC.

Duns Number:175697908

Device Description: Intended to deliver illumination from a high intensity light source and to aspirate from t Intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.

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More Product Details

Catalog Number

1911273

Brand Name

Eigr™ Saber Waveguide

Version/Model Number

Frazier, 12Fr

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"

Yes

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

JOL

Product Code Name

Catheter And Tip, Suction

Device Record Status

Public Device Record Key

935080fb-99fb-4ba9-8cf4-040c17101bd3

Public Version Date

April 24, 2020

Public Version Number

6

DI Record Publish Date

July 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INVUITY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 28