Eyetec - Carton Label - Eye Wick - NETWORK MEDICAL PRODUCTS LIMITED

Duns Number:458670304

Device Description: Carton Label - Eye Wick

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More Product Details

Catalog Number

-

Brand Name

Eyetec

Version/Model Number

40-431-USA

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130117,K130117

Product Code Details

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Device Record Status

Public Device Record Key

b17f73fb-6b70-4055-9556-70fa79078400

Public Version Date

February 22, 2021

Public Version Number

3

DI Record Publish Date

August 28, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NETWORK MEDICAL PRODUCTS LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 329
2 A medical device with a moderate to high risk that requires special controls. 51