Parametrium Clamp - adeor Medical AG

Duns Number:341188943

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More Product Details

Catalog Number

16076GY

Brand Name

Parametrium Clamp

Version/Model Number

slightly curved 240 mm

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

KOH

Product Code Name

Instrument, Manual, General Obstetric-Gynecologic

Device Record Status

Public Device Record Key

5c1c1f9d-6fd3-4ef9-9d55-a8ec33f0020f

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADEOR MEDICAL AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 535