FDA.reportPublic FDA data

CoreBloc

Primary DI
07350081910099
Brand
CoreBloc
Company
Prostalund AB
Model
SK820000
Catalog number
SK820000
Published
2018-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27350081910093PackageGS110In Commercial Distribution
07350081910099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2735008191009327350081910093
07350081910099073500819100997350081910099

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous medicine administration kit, non-medicated, single-useA collection of sterile devices intended to be used to administer various types of medication (non-dedicated) by injection. It will typically contain a syringe, a needle, extension tubing, adaptors, and antiseptic applicator, but not the medication. This is a single-use device.

Regulatory Flags#

DUNS number
554703897
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350081910013CoreThermMicrowave Antenna StandardAN8060012016-03-07
07350081910020CoreThermIntraprostatic Temperature Probe StandardIP8076012016-03-07
07350081910037CoreThermRectal Temperature ProbeRP8096012016-03-07
07350081910044CoreThermPenis Safety ProbeSP8086012016-03-07
07350081910051CoreThermCatheter StandardCA8042202016-03-07
07350081910068CoreThermMicrowave Antenna ShortAN8061012016-03-07
07350081910075CoreThermIntraprostatic Temperature Probe ShortIP8071012016-03-07
07350081910082CoreThermCatheter ShortCA8041202016-03-07
27350081910093CoreBlocSK820000SK8200002018-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144017596Metier MedicalMETIER MEDICAL LTDGAA2026-10-19
00860015723901NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723918NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723925NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723932NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
10198956491298CARDINAL HEALTHCardinal Health 200, LLCGAA2026-10-12
00817295020138InradInradGAA2026-10-09
00817295020145InradInradGAA2026-10-09
00817295020183InradInradGAA2026-10-09
00817295020190InradInradGAA2026-10-09
00817295020206InradInradGAA2026-10-09
00817295020213InradInradGAA2026-10-09
00817295020220InradInradGAA2026-10-09
00817295020237InradInradGAA2026-10-09
00817295020244InradInradGAA2026-10-09
00817295020251InradInradGAA2026-10-09
00817295020268InradInradGAA2026-10-09
00817295020275InradInradGAA2026-10-09
00817295020282InradInradGAA2026-10-09
00817295020299InradInradGAA2026-10-09
00817295020305InradInradGAA2026-10-09
00817295020312InradInradGAA2026-10-09
00817295020329InradInradGAA2026-10-09
00817295020336InradInradGAA2026-10-09
00817295020343InradInradGAA2026-10-09
00817295020350InradInradGAA2026-10-09
00817295020367InradInradGAA2026-10-09
00817295020374InradInradGAA2026-10-09
00817295020381InradInradGAA2026-10-09
00817295020398InradInradGAA2026-10-09