S4 CERVICAL - S4C FAVOURED ANGLE SCREW 4.0X28MM - Aesculap AG

Duns Number:315018218

Device Description: S4C FAVOURED ANGLE SCREW 4.0X28MM

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

SW150T

Brand Name

S4 CERVICAL

Version/Model Number

SW150T

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)

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

MNI

Product Code Name

ORTHOSIS, SPINAL PEDICLE FIXATION

Device Record Status

Public Device Record Key

f7008af5-4b23-4d86-a7aa-26244f31908f

Public Version Date

April 12, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2015

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