EXTERNAL OCULID TAN® - 1,0 g - EXTERNAL OCULID TAN® - 1,0 g - FCI S A S FCI 20 22

Duns Number:763408366

Device Description: EXTERNAL OCULID TAN® - 1,0 g

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More Product Details

Catalog Number

-

Brand Name

EXTERNAL OCULID TAN® - 1,0 g

Version/Model Number

S3.60102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

MML

Product Code Name

Weights, Eyelid, External

Device Record Status

Public Device Record Key

69279c3b-35ab-4e9b-8d15-fcd82dd97984

Public Version Date

March 16, 2022

Public Version Number

1

DI Record Publish Date

March 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FCI S A S FCI 20 22" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 291
U Unclassified 60