FDA.report

Seed Implant Needle

Primary DI
20801741124116
Brand
Seed Implant Needle
Company
C. R. Bard, Inc.
Model
818205
Catalog number
818205
Device description
BrachyStar FastFill Seed Implant Needle with Antistatic Plastic Hub, Bone Wax Tip Insert and Lubricious Coating, 18g x 20cm Length
Published
2020-09-21
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
20801741124116PackageGS110In Commercial Distribution
10801741124119PrimaryGS10
00801741124112Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
2080174112411614208017411241162Indicator 2 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
1080174112411914108017411241191Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
00801741124112140080174112411208017411241120801741124112Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

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 Gauge18Gauge

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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