FDA.report

VISICOIL

Primary DI
EIBAFP00100
Brand
VISICOIL
Company
RADIOMED CORP
Model
FP-0010
Catalog number
FP-0010
Device description
0.35 mm x 2 cm VISICOIL
Published
2016-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications

CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EIBAFP00100PrimaryHIBCC0

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
Radiation Sterilization

Contacts

PhoneEmail
+1-901-432-4202visicoil@iba-group.com

Regulatory Flags

DUNS number
036545713
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
true

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B887SN035010PL200VISICOILSN-035-010-PL20SN-035-010-PL202022-07-18
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B887SNMR05002021150VISICOIL MRSNMR-050-020-2115SNMR-050-020-21152022-07-18
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B887SNMR05002021080VISICOIL MRSNMR-050-020-2108SNMR-050-020-21082022-07-18
B887SNMR05000521200VISICOIL MRSNMR-050-005-2120SNMR-050-005-21202022-06-24
B8870010010X-MARK0010010010012022-06-17
B8870010020X-MARK0010020010022022-06-17
B8870010030X-MARK0010030010032022-06-17
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