MICRO-LINE - micro-Line sagittal saw - Aesculap AG

Duns Number:315018218

Device Description: micro-Line sagittal saw

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More Product Details

Catalog Number

GD307

Brand Name

MICRO-LINE

Version/Model Number

GD307

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

HAB

Product Code Name

SAW, POWERED, AND ACCESSORIES

Device Record Status

Public Device Record Key

b4c2a267-f4fe-4e01-8581-d895f5a53e15

Public Version Date

September 14, 2022

Public Version Number

4

DI Record Publish Date

July 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AESCULAP AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11840
2 A medical device with a moderate to high risk that requires special controls. 7088
3 A medical device with high risk that requires premarket approval 37