devemed - PPS Periosteal elevator # Z3for lateral tunnel - devemed GmbH

Duns Number:506826739

Device Description: PPS Periosteal elevator # Z3for lateral tunnel proceduresfor tunnel procedures 1.6 <>1 PPS Periosteal elevator # Z3for lateral tunnel proceduresfor tunnel procedures 1.6 <>1.8 mmF-LINE SL double ended

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More Product Details

Catalog Number

-

Brand Name

devemed

Version/Model Number

PPS 1450 F

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

HTE

Product Code Name

Elevator

Device Record Status

Public Device Record Key

4a8f9eb4-d9ff-48c5-b99c-d20efc22484e

Public Version Date

June 30, 2021

Public Version Number

3

DI Record Publish Date

April 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEVEMED GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2521