SYMPHONY - SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER - Medos International Sàrl

Duns Number:482661753

Device Description: SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE

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More Product Details

Catalog Number

202000401

Brand Name

SYMPHONY

Version/Model Number

2020-00-401

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

K191943

Product Code Details

Product Code

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

08f9cc72-d534-4d81-99dc-60bab4c7aa1d

Public Version Date

August 19, 2020

Public Version Number

2

DI Record Publish Date

May 22, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDOS INTERNATIONAL SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 972
2 A medical device with a moderate to high risk that requires special controls. 6382
3 A medical device with high risk that requires premarket approval 20
U Unclassified 20