FDA.report

X-Seed

Primary DI
EIBA2850033
Brand
X-Seed
Company
RADIOMED CORP
Model
285003
Catalog number
285003
Device description
0.85mm x 5mm X-SEED Three Pack
Published
2017-03-16
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

Related Records

Contact Domains

Product Codes

CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EIBA2850033PrimaryHIBCC0
EIBA2850030Unit of UseHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
9014327202visicoil@iba-group.com

Regulatory Flags

DUNS number
036545713
Device count
3
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

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B887SNMR05001021080VISICOIL MRSNMR-050-010-2108SNMR-050-010-21082022-07-18
B887SNMR05002021080VISICOIL MRSNMR-050-020-2108SNMR-050-020-21082022-07-18
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B8870010010X-MARK0010010010012022-06-17
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