NA - TUR module for Operon D 850, US. Keep Dry. - Berchtold Holding GmbH

Duns Number:316153824

Device Description: TUR module for Operon D 850, US. Keep Dry.

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More Product Details

Catalog Number

OZ 1705675

Brand Name

NA

Version/Model Number

OZ 1705675

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

CCX

Product Code Name

SUPPORT, PATIENT POSITION

Device Record Status

Public Device Record Key

c12f65bc-8745-42d6-9f11-ccd5f571a23d

Public Version Date

June 02, 2021

Public Version Number

1

DI Record Publish Date

May 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BERCHTOLD HOLDING GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 2