ClearCut®; Intrepid - ClearCut® HP2 Slit Knife Intrepid micro-coaxial - Alcon Laboratories, Inc.

Duns Number:008018525

Device Description: ClearCut® HP2 Slit Knife Intrepid micro-coaxial system 2.0 DB

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More Product Details

Catalog Number

-

Brand Name

ClearCut®; Intrepid

Version/Model Number

8065982065

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

HNN

Product Code Name

Knife, ophthalmic

Device Record Status

Public Device Record Key

ea1b832c-3853-4042-864b-ca190ef2eab8

Public Version Date

August 26, 2020

Public Version Number

1

DI Record Publish Date

August 18, 2020

Additional Identifiers

Package DI Number

10380659820653

Quantity per Package

6

Contains DI Package

00380659820656

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ALCON LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 250
2 A medical device with a moderate to high risk that requires special controls. 541
3 A medical device with high risk that requires premarket approval 6098