Opthalmic Spatula - MEMBRANE SPATULA HOOKED SHORT LENGTH 20G - OVATION INTERNATIONAL

Duns Number:879324241

Device Description: MEMBRANE SPATULA HOOKED SHORT LENGTH 20G

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More Product Details

Catalog Number

-

Brand Name

Opthalmic Spatula

Version/Model Number

OI-2284T-20G

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

HND

Product Code Name

Spatula, Ophthalmic

Device Record Status

Public Device Record Key

84cadf98-45c2-46fa-8b7e-a6f54fbc610d

Public Version Date

January 31, 2022

Public Version Number

1

DI Record Publish Date

January 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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