FDA.report

Cook

Primary DI
00827002176188
Brand
Cook
Company
COOK INCORPORATED
Model
G17618
Catalog number
CBNS-018020
Device description
Cook Brachytherapy Needle Set
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
IWJSystem, applicator, radionuclide, manual

Product Code Classifications

CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002176188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002176188008270021761888270021761880827002176188

GMDN Terms

TermDefinition
Prostate brachytherapy system applicator, remote-afterloadingA remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the prostate. It is designed for temporary implantation within the prostate and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components.

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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10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
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