MONDEAL - Depth measuring gauge Ø Screw 2.7-3.5 mmØ probe - MONDEAL Medical Systems GmbH

Duns Number:312546955

Device Description: Depth measuring gauge Ø Screw 2.7-3.5 mmØ probe 1.7 mm, M2/M3 measuremen Depth measuring gauge Ø Screw 2.7-3.5 mmØ probe 1.7 mm, M2/M3 measurement range 0 - 80 mm

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More Product Details

Catalog Number

27-08036

Brand Name

MONDEAL

Version/Model Number

27-08036

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 07, 2021

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"

Yes

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

ffd6a66a-043a-41c4-be40-60e58d4795e8

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

June 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MONDEAL MEDICAL SYSTEMS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 274
2 A medical device with a moderate to high risk that requires special controls. 565