FDA.reportPublic FDA data

Percutaneous Entry Needle

Primary DI
00886333208463
Brand
Percutaneous Entry Needle
Company
ARGON MEDICAL DEVICES, INC.
Model
195326
Catalog number
195326
Device description
Percutaneous Entry Needle - 18ga x 2 7/8” (7.3cm)
Published
2016-09-10
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
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K772369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K772369000NEEDLES USED IN ANGIOGRAPHIC PROCED.Argon Medical Corp.1978-01-24DRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886333208460PackageGS110In Commercial Distribution
20886333208467PackageGS1150In Commercial Distribution
00886333208463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088633320846010886333208460
2088633320846720886333208467
00886333208463008863332084638863332084630886333208463

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction needleA sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). This is a single-use device.

Device Sizes#

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

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

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