SAVI SCOUT®

Primary DI
10852205006090
Brand
SAVI SCOUT®
Company
CIANNA MEDICAL, INC.
Model
SH-01
Catalog number
SH-01
Device description
Sheath, Guide, SAVI SCOUT®
Published
2017-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBYTemporary Tissue Marker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBYTemporary Tissue MarkerGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852205006090PackageGS120In Commercial Distribution
00852205006093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085220500609010852205006090
00852205006093008522050060938522050060930852205006093

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, 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.

Sterilization Methods#

Method table
Method

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00852205006062SAVI SCOUT®CHK-01CHK-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719992742516Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742509Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742530Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742592Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742882Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742943Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742974Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742998Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
10855436007041LOCalizerHEALTH BEACONS INCPBY2018-05-03
10855436007058LOCalizerHEALTH BEACONS INCPBY2018-05-03
10855436007065LOCalizerHEALTH BEACONS INCPBY2018-05-03
00852205006017SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006024SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006031SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006048SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006093SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
10852205006014SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006055SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006062SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006079SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006086SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00855436007013LOCalizerHEALTH BEACONS, INC.PBY2017-06-16
00855436007020LOCalizerHEALTH BEACONS, INC.PBY2017-06-16
10855436007010LOCalizerHEALTH BEACONS INCPBY2017-06-16
10855436007027LOCalizerHEALTH BEACONS INCPBY2017-06-16
00855436007037LOCalizerHEALTH BEACONS, INC.PBY2017-06-16