Americot - Americot Blue 1/2" x 1/2" Non Sterile - AMERICAN SURGICAL COMPANY, LLC

Duns Number:151054954

Device Description: Americot Blue 1/2" x 1/2" Non Sterile

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More Product Details

Catalog Number

-

Brand Name

Americot

Version/Model Number

20-04SNS

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

K854713

Product Code Details

Product Code

HBA

Product Code Name

Neurosurgical Paddie

Device Record Status

Public Device Record Key

33ca3b00-0941-40a1-88b7-31771137482b

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN SURGICAL COMPANY, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19