FDA.report

Seed Implant Needle

Primary DI
20801741075944
Brand
Seed Implant Needle
Company
C. R. Bard, Inc.
Model
917205
Catalog number
917205
Device description
BrachyStar Brachytherapy Applicator Seed Implant Needle with Lubricious Coating and cm Markings, 17g x 20cm Length
Published
2020-09-22
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
20801741075944PackageGS110In Commercial Distribution
10801741075947PrimaryGS10
00801741075940Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2080174107594420801741075944
1080174107594710801741075947
00801741075940008017410759408017410759400801741075940

GMDN Terms

TermDefinition
Brachytherapy needleA sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.

Device Sizes

TypeValueUnit
Needle Gauge17Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags

DUNS number
016898496
Device count
5
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
false
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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