FDA.reportPublic FDA data

Bone Access Needle

Primary DI
00886333222940
Brand
Bone Access Needle
Company
ARGON MEDICAL DEVICES, INC.
Model
DBANJ1104TL
Catalog number
DBANJ1104TL
Device description
Bone Access Needle 11ga x 4in
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXNProbe, Test, Heart-Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXNProbe, Test, Heart-ValveCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333222944PackageGS110In Commercial Distribution
00886333222940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633322294420886333222944
00886333222940008863332229408863332229400886333222940

GMDN Terms#

Term, Definition table
TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Away from Sunlight

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333003594Breast Localization Needles231075G231075G2022-07-05
00886333003600Breast Localization Needles231030G231030G2022-07-05
00886333003617Breast Localization Needles231050G231050G2022-07-05
00886333003624Breast Localization Needles231125G231125G2022-07-05
00886333003631Breast Localization Needles231100G231100G2022-07-05
00886333003648Breast Localization Needles2420502420502022-06-30
00886333003655Breast Localization Needles2420752420752022-06-30
00886333003662Breast Localization Needles2421002421002022-06-30
00886333003679Breast Localization Needles2421252421252022-06-29
00886333003686Breast Localization Needles2430752430752022-06-29
00886333003693Breast Localization Needles2431252431252022-07-05
00886333003709Breast Localization Needles2430502430502022-06-29
00886333003723Breast Localization Needles2430302430302022-06-29
00886333003730Breast Localization Needles2440302440302022-06-30
00886333003747Breast Localization Needles2440502440502022-06-30
00886333003754Breast Localization Needles2440752440752022-06-29
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M7408606028Duo Ti Expandable Interbody Fusion SystemSPINEOLOGY INC.LXN2023-12-29
M7405210002Universal Dilator SPINEOLOGY INC.LXN2023-12-19
M7405230003Universal Dilator SPINEOLOGY INC.LXN2023-12-19
00851788001167On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.LXN2023-08-09
05415067042316NAST. JUDE MEDICAL, INC.LXN2023-05-19
15415067042313NAST. JUDE MEDICAL, INC.LXN2023-05-19
00896208000269Leaflet TesterCorcym Canada CorpLXN2021-04-20
M944AL105710Wexler Surgical, Inc.WEXLER SURGICAL, INC.LXN2020-07-31
20886333222944Bone Access NeedleARGON MEDICAL DEVICES, INC.LXN2016-09-21