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
00886333209859L-Cath PICC3844663844662026-10-14
00886333006151Skater Nephrostomy Drainage Catheter7556060257556060252026-10-07
00886333006168Skater Nephrostomy Drainage Catheter7556140357556140352026-10-07
00886333006175Skater Nephrostomy Drainage Catheter7556120357556120352026-10-07
00886333006182Skater Nephrostomy Drainage Catheter7556080357556080352026-10-07
00886333006199Skater Nephrostomy Catheter7556100357556100352026-10-07
00886333006205Skater All-Purpose Drainage Catheter7560060207560060202026-10-07
00886333006212Skater All-Purpose Drainage Catheter7560070207560070202026-10-07
00886333006229Skater All-Purpose Drainage Catheter7560120257560120252026-10-07
00886333006236Skater All-Purpose Drainage Catheter7560100257560100252026-10-07
00886333006243Skater All-Purpose Drainage Catheter7560080257560080252026-10-07
00886333006250Skater All-Purpose Drainage Catheter7565140257565140252026-10-07
00886333006267Skater All-Purpose Drainage Catheter7565160257565160252026-10-07
00886333006274Skater All-Purpose Drainage Catheter7565120257565120252026-10-07
00886333006281Skater All-Purpose Drainage Catheter7565100307565100302026-10-07
00886333006298Skater All-Purpose Drainage Catheter7565100257565100252026-10-07
00886333006304Skater All-Purpose Drainage Catheter7565080307565080302026-10-07
00886333006311Skater All-Purpose Drainage Catheter7565080257565080252026-10-07
00886333006328Skater All-Purpose Drainage Catheter7565070257565070252026-10-07
00886333006335Skater All-Purpose Drainage Catheter7565060207565060202026-10-07

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