Enucleation/Evisceration Sizers (set) - Enucleation/Evisceration Sizers (set: 14, 16, 18, - Oculo-Plastik Inc

Duns Number:257382580

Device Description: Enucleation/Evisceration Sizers (set: 14, 16, 18, 20 & 22 mm)

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More Product Details

Catalog Number

-

Brand Name

Enucleation/Evisceration Sizers (set)

Version/Model Number

A1-SET

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)

-

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

FTY

Product Code Name

Tape, Measuring, Rulers And Calipers

Device Record Status

Public Device Record Key

74f8fc9a-0405-4828-aea3-c265f905ccea

Public Version Date

December 03, 2019

Public Version Number

1

DI Record Publish Date

November 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OCULO-PLASTIK INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 192
2 A medical device with a moderate to high risk that requires special controls. 88