FDA.reportPublic FDA data

Cook

Primary DI
00827002193802
Brand
Cook
Company
COOK INCORPORATED
Model
G19380
Catalog number
DXRBL-18-9.0
Device description
X-Reidy Breast Lesion Localization Needle
Published
2020-10-02
Public version status
New
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
00827002193802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002193802008270021938028270021938020827002193802

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, 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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009883703Mammo-Flex Quad-Flex Localization SystemDfc Medical LLCMIJ2023-10-17
48033003340347ALM SETH.S. HOSPITAL SERVICE SPAMIJ2023-04-19
18059174746985MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-07-15
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
04250195605825MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195605832MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604767Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604774Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604781Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604590Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604583Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604606Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
00815212024108DKBL-20-15.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024115DKBL-20-5.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024122DKBL-20-7.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024139DKBL-20-9.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024146DKBL-21-15.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024153DKBL-21-5.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024160DKBL-21-7.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024177DKBL-21-9.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024184DKBL-20-7.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024191DKBL-20-5.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024207DKBL-20-9.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024214DKBL-21-5.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024221DKBL-21-7.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024238DKBL-21-9.0-A-UIzi Medical Products, LLCMIJ2021-10-12