PRO-PAKS®️ - Eye Fluid Wick. Our effective synthetic PVA - MICROSPECIALITIES, INC.

Duns Number:013469890

Device Description: Eye Fluid Wick. Our effective synthetic PVA sponges and fluid management items are highly Eye Fluid Wick. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. 20/box.

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More Product Details

Catalog Number

MK-503

Brand Name

PRO-PAKS®️

Version/Model Number

MK-503

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

HOZ

Product Code Name

Sponge, Ophthalmic

Device Record Status

Public Device Record Key

fac89f36-9315-4650-adea-e7e280e7a77d

Public Version Date

November 30, 2018

Public Version Number

1

DI Record Publish Date

October 30, 2018

Additional Identifiers

Package DI Number

30810003220098

Quantity per Package

20

Contains DI Package

10810003220094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MICROSPECIALITIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 87
U Unclassified 5