ADHESIVE STRIPS - ADHESIVE STRIPS - FCI S A S FCI 20 22

Duns Number:763408366

Device Description: ADHESIVE STRIPS

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More Product Details

Catalog Number

-

Brand Name

ADHESIVE STRIPS

Version/Model Number

S3.0500

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)

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

b3aed787-74d7-49ef-8a8a-e8c7741adf51

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