Amplatz - Clear Amplatz Sheath With Radiopaque Stripe - COOK INCORPORATED

Duns Number:042823948

Device Description: Clear Amplatz Sheath With Radiopaque Stripe

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More Product Details

Catalog Number

CAS-180017

Brand Name

Amplatz

Version/Model Number

G46030

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

KOE

Product Code Name

DILATOR, URETHRAL

Device Record Status

Public Device Record Key

e9f7cd8e-f676-440f-b1d9-72776cba2204

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COOK INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 669
2 A medical device with a moderate to high risk that requires special controls. 8328
3 A medical device with high risk that requires premarket approval 370
U Unclassified 242