FDA.reportPublic FDA data

(10) Applicator End Cap, 50 mm

Primary DI
00858012005441
Brand
(10) Applicator End Cap, 50 mm
Company
Icad, Inc.
Model
720299
Catalog number
SK3550
Device description
Surface Applicator End Cap, 50 mm, 10-Pack
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K083734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083734000AXXENT SURFACE APPLICATOR, MODEL 710257Xoft, Inc.2009-02-11JAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858012005441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858012005441008580120054418580120054410858012005441

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative/postoperative therapeutic x-ray system surface applicatorA non-sterile component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source for direct patient contact when the system is used for the treatment of certain clinical conditions (e.g., skin tumours). It has a flat distal end that is typically used to irradiate a body surface treatment site, e.g., skin that does not need surgical exposure. It is typically supplied in a range of sizes (diameters). This is a reusable device intended to be sterilized prior to use.

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
Primary DIBrandModelCatalogPublished
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00850008977312PowerLook MammoAI Container - SectraDSC026-012024-06-10
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00850008977343PowerLook 11112024-06-10
00850008977350PowerLook MammoAI Container - GE1.02024-06-07
00850008977367PowerLook 11.111.12024-06-07
00850008977374PowerLook PRO+, OUSDSC030-01, DSC030-02, DSC030-032024-06-07
00850008977381PowerLook PRO+ 2GPU Tower Platform, USDSC029-01, DSC029-02, DSC029-032024-06-07
00850008977398PowerLook PRO+ Rack-Mount, OUSDSC034-01, DSC034-02, DSC034-032024-06-07
00850008977404PowerLook PRO+ Rack-Mount, USDSC033-01, DSC033-02, DSC033-032024-06-07
00850008977411PowerLook PRO+ 4GPU Tower Platform, USDSC031-01, DSC031-02, DSC031-032024-06-07
00850008977534PowerLook AI Mammo Container 1.0.0 BlackfordDSC036-012024-06-07
00850008977428PowerLook PRO+ 4GPU Tower Platform, OUSDSC032-01, DSC032-02, DSC032-032023-07-14

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Primary DI, Brand, Company table
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