FDA.report

Cook

Primary DI
00827002194182
Brand
Cook
Company
COOK INCORPORATED
Model
G19418
Catalog number
DXRBL-18-5.0
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

Related Records

Contact Domains

Product Codes

CodeName
MIJNEEDLE, TUMOR LOCALIZATION

Product Code Classifications

CodeDeviceSpecialtyClass
MIJNeedle, Tumor LocalizationGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002194182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002194182008270021941828270021941820827002194182

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

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

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10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

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