FDA.reportPublic FDA data

Rigid Shield 3 cm

Primary DI
00858012005274
Brand
Rigid Shield 3 cm
Company
Icad, Inc.
Model
710706
Catalog number
F5350-3
Device description
Rigid Shield 3 cm
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JADSystem, Therapeutic, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JADSystem, Therapeutic, X-RayRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111299000AXXENT RADIATION SHIELD - RIGIDXoft, an Icad Company2011-07-20JAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858012005274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858012005274008580120052748580120052740858012005274

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding apronA full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
108870254
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
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00850008977381PowerLook PRO+ 2GPU Tower Platform, USDSC029-01, DSC029-02, DSC029-032024-06-07
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00850008977404PowerLook PRO+ Rack-Mount, USDSC033-01, DSC033-02, DSC033-032024-06-07
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00850008977428PowerLook PRO+ 4GPU Tower Platform, OUSDSC032-01, DSC032-02, DSC032-032023-07-14

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