ERCP - HERAEUS MEDICAL COMPONENTS LLC

Duns Number:868303074

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More Product Details

Catalog Number

-

Brand Name

ERCP

Version/Model Number

GI132

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

-

Product Code Details

Product Code

OCY

Product Code Name

Endoscopic Guidewire, Gastroenterology-Urology

Device Record Status

Public Device Record Key

3cdcd2ff-b787-46dd-95ad-afa4bae07a4d

Public Version Date

August 24, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HERAEUS MEDICAL COMPONENTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 91