SAVI SCOUT® - 7.5 cm Delivery Needle and Reflector, SAVI SCOUT® - CIANNA MEDICAL, INC.

Duns Number:807876284

Device Description: 7.5 cm Delivery Needle and Reflector, SAVI SCOUT®

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More Product Details

Catalog Number

SSR75-01

Brand Name

SAVI SCOUT®

Version/Model Number

SSR75-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

NEU

Product Code Name

Marker, Radiographic, Implantable

Device Record Status

Public Device Record Key

ec1a4ec3-8fa4-4427-a711-4e3ac2b979c1

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 22, 2017

Additional Identifiers

Package DI Number

10852205006021

Quantity per Package

5

Contains DI Package

00852205006024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"CIANNA MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9