Ophthalmic Knife - SLIT KNIFE 2.70 MM ANGLED 45° CLEAR CORNEA, - OVATION INTERNATIONAL

Duns Number:879324241

Device Description: SLIT KNIFE 2.70 MM ANGLED 45° CLEAR CORNEA, SAFETY

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More Product Details

Catalog Number

-

Brand Name

Ophthalmic Knife

Version/Model Number

OVS6227CC

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

69ae58ac-1adb-4d1e-88ec-9f5e47a93707

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 07, 2022

Additional Identifiers

Package DI Number

08903317020780

Quantity per Package

6

Contains DI Package

08903317014802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OVATION INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 161