Latex-free Rubber Suction Cups (100 units) - Latex-free Rubber Suction Cups (100 units) - Oculo-Plastik Inc

Duns Number:257382580

Device Description: Latex-free Rubber Suction Cups (100 units)

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More Product Details

Catalog Number

-

Brand Name

Latex-free Rubber Suction Cups (100 units)

Version/Model Number

5360LF-1

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"

Yes

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

KYE

Product Code Name

Inserter/Remover Contact Lens

Device Record Status

Public Device Record Key

8320ff07-19b8-4161-ac52-64f306608358

Public Version Date

November 18, 2019

Public Version Number

1

DI Record Publish Date

November 08, 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