FDA.reportPublic FDA data

SAVI SCOUT®

Primary DI
00852205006062
Brand
SAVI SCOUT®
Company
CIANNA MEDICAL, INC.
Model
CHK-01
Catalog number
CHK-01
Device description
Console, SCOUT® Check
Published
2017-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable
PBYTemporary Tissue Marker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2
PBYTemporary Tissue MarkerGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852205006062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852205006062008522050060628522050060620852205006062

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.

Contacts#

Phone, Email table
PhoneEmail
866-920-9444info@ciannamedical.com

Regulatory Flags#

DUNS number
807876284
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852205006017SAVI SCOUT®SSR05-01SSR05-012017-11-22
00852205006024SAVI SCOUT®SSR75-01SSR75-012017-11-22
00852205006031SAVI SCOUT®SSR10-01SSR10-012017-11-22
00852205006048SAVI SCOUT®HPSU-01HPSU-012017-11-22
00852205006093SAVI SCOUT®SH-01SH-012017-11-22
00852205006055SAVI SCOUT®SSC-01SSC-012017-11-22
00852205006079SAVI SCOUT®CHKHP-01CHKHP-012017-11-22
00852205006086SAVI SCOUT®SG-01SG-012017-11-22
10852205006014SAVI SCOUT®SSR05-01SSR05-012017-11-22
10852205006021SAVI SCOUT®SSR75-01SSR75-012017-11-22
10852205006038SAVI SCOUT®SSR10-01SSR10-012017-11-22
10852205006045SAVI SCOUT®HPSU-01HPSU-012017-11-22
10852205006090SAVI SCOUT®SH-01SH-012017-11-22

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Primary DI, Brand, Company table
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