FDA.reportPublic FDA data

Kopans

Primary DI
00827002012585
Brand
Kopans
Company
COOK INCORPORATED
Model
G01258
Catalog number
DKBL-21-15.0
Device description
Kopans Breast Lesion Localization Needle
Published
2020-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIJNEEDLE, TUMOR LOCALIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIJNeedle, Tumor LocalizationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002012585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002012585008270020125858270020125850827002012585

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02
00827002121607KopansG12160IDKBL-20-5.0-A2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009883703Mammo-Flex Quad-Flex Localization SystemDfc Medical LLCMIJ2023-10-17
08033003340349ALM SETH.S. HOSPITAL SERVICE SPAMIJ2023-04-19
48033003340347ALM SETH.S. HOSPITAL SERVICE SPAMIJ2023-04-19
08059174746964MEDWIREMEDAX SRL UNIPERSONALEMIJ2023-01-03
08059174747084MEDWIREMEDAX SRL UNIPERSONALEMIJ2023-01-03
08059174746971MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747008MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747091MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747107MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747121MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174746988MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-07-15
18059174746985MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-07-15
04250195600837TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600844TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600851TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600899Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600905Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195601605MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195601612MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195602046Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195602053Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195602060Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195603005Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195603029Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195603036Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604705TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604712TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604729TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604798Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604804Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28