STOMA® - File, Orban 010-11, oral-facial - Storz am Mark GmbH

Duns Number:318268125

Device Description: File, Orban 010-11, oral-facial

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More Product Details

Catalog Number

12910.00

Brand Name

STOMA®

Version/Model Number

12910.00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EMI

Product Code Name

FILE, BONE, SURGICAL

Device Record Status

Public Device Record Key

fbcaac71-8262-4f06-94bc-3df513a6c394

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

August 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STORZ AM MARK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1204
2 A medical device with a moderate to high risk that requires special controls. 2