ACCLARENT CYCLOPS - ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE - - ACCLARENT, INC.

Duns Number:361092450

Device Description: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE - REFURBISHED

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More Product Details

Catalog Number

CYE002R

Brand Name

ACCLARENT CYCLOPS

Version/Model Number

CYE002R

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

EOB

Product Code Name

NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Device Record Status

Public Device Record Key

cae6fca4-4054-4de7-b843-14f105c52125

Public Version Date

January 22, 2020

Public Version Number

3

DI Record Publish Date

September 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