OCULAR OCCLUDER (HYPOALLERGENIC ADHESIVE TAPE) - Gyrus Acmi, Inc.

Duns Number:007198742

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More Product Details

Catalog Number

-

Brand Name

OCULAR OCCLUDER (HYPOALLERGENIC ADHESIVE TAPE)

Version/Model Number

890070

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Device Record Status

Public Device Record Key

fc326c16-e9ea-40c7-a18e-8e0972d98dbe

Public Version Date

August 09, 2019

Public Version Number

2

DI Record Publish Date

September 13, 2018

Additional Identifiers

Package DI Number

00821925022959

Quantity per Package

6

Contains DI Package

00821925040281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GYRUS ACMI, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 899
2 A medical device with a moderate to high risk that requires special controls. 1586
3 A medical device with high risk that requires premarket approval 9
U Unclassified 4