FDA.reportPublic FDA data

ABSORBER SHIELD

Primary DI
08057014730425
Brand
ABSORBER SHIELD
Company
S.I.T. SORDINA IORT TECHNOLOGIES SPA
Model
Diameter 50 mm
Catalog number
N394050-02-05
Device description
The absorber shields are discs used to radioprotect the patient’s organs . They shall beinserted below the tissue treated during the surgery. They can be inserted within the surgicalincision.
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112286000NOVAC 11New Radiant Technology S.P.A.2012-04-19IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057014730425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057014730425080570147304258057014730425

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding blanketA personal protective device intended to shield selected body parts of a patient, or others, from unnecessary exposure to radiation during diagnostic or therapeutic medical or dental procedures. Radiation protection blankets used in diagnostic x-ray and nuclear medicine typically consist of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material. Blankets intended to attenuate neutrons are composed of hydrogenous materials instead of lead. Blankets used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference50Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
339852325
Device count
1
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057014731224LIAC HWL10 MeV9000910012026-04-30
08057014731231LIAC HWL12 MeV9000910022026-04-30
08057014730050LIAC10 MeV9000500012016-09-12
08057014730067LIAC12 MeV9000500022016-09-12
08057014730432ABSORBER SHIELDDiameter 60 mm N394060-02-052016-09-12
08057014730449ABSORBER SHIELDDiameter 70 mmN394070-02-052016-09-12
08057014730456ABSORBER SHIELDDiameter 80 mmN394080-02-052016-09-12
08057014730463ABSORBER SHIELDDiameter 90 mmN394090-02-052016-09-12
08057014730470ABSORBER SHIELDDiameter 100 mmN394100-02-052016-09-12
08057014730487NOVAC1110 MeVN300000-01-032016-09-12

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Primary DI, Brand, Company table
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