Synergy®Cranial - SW 9733763 SYNERGY CRANIAL S7 2.2.9 - MEDTRONIC NAVIGATION, INC.

Duns Number:835233107

Device Description: SW 9733763 SYNERGY CRANIAL S7 2.2.9

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More Product Details

Catalog Number

-

Brand Name

Synergy®Cranial

Version/Model Number

9733763

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

K221087

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

f207d04e-2612-47b4-b96b-b2f531cd360a

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC NAVIGATION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 1961
3 A medical device with high risk that requires premarket approval 1