FDA.reportPublic FDA data

ABSORBER SHIELD

Primary DI
08057014730449
Brand
ABSORBER SHIELD
Company
S.I.T. SORDINA IORT TECHNOLOGIES SPA
Model
Diameter 70 mm
Catalog number
N394070-02-05
Device description
The absorber shields are discs used to radioprotect the patient’s organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision.
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
08057014730449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057014730449080570147304498057014730449

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
Circumference70Millimeter

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

Contacts#

Phone, Email table
PhoneEmail
+390692062446giuseppe.carella@sordina.com
+390692062446alessia.giaffreda@soiort.com

Regulatory Flags#

DUNS number
339852325
Device count
1
Lot or batch
true
Manufacturing date on label
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
08057014730425ABSORBER SHIELDDiameter 50 mmN394050-02-052016-09-12
08057014730432ABSORBER SHIELDDiameter 60 mm N394060-02-052016-09-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22