Gamma Finder Sterile Sleeve - W.O.M. World of Medicine GmbH

Duns Number:316305242

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More Product Details

Catalog Number

-

Brand Name

Gamma Finder Sterile Sleeve

Version/Model Number

GMSLV001-50

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

IZD

Product Code Name

Probe, Uptake, Nuclear

Device Record Status

Public Device Record Key

7c3f9230-d0c3-458f-ad7b-ca4a8d50de15

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 25, 2016

Additional Identifiers

Package DI Number

04056702004187

Quantity per Package

50

Contains DI Package

04056702004170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"W.O.M. WORLD OF MEDICINE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64
2 A medical device with a moderate to high risk that requires special controls. 77