FDA.reportPublic FDA data

Adult Myelography Tray

Primary DI
00886333220649
Brand
Adult Myelography Tray
Company
ARGON MEDICAL DEVICES, INC.
Model
A4324AWSP
Catalog number
A4324AWSP
Device description
Adult Myelography Tray
Published
2016-09-16
Public version status
Update
Distribution status
Not 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
OGJNerve Block Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333220643PackageGS110Not in Commercial Distribution
00886333220649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633322064320886333220643
00886333220649008863332206498863332206490886333220649

GMDN Terms#

Term, Definition table
TermDefinition
Myelography kitA collection of devices designed for injecting contrast medium into the subarachnoid (intrathecal) space (usually of the lumbar spine) for the purposes of visualizing the spinal canal by radiographic study. It is also referred to as myelogram tray and typically includes a needle, syringe, tubing, contrast medium, and other consumable items. 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
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333210893Guidewire3951263951262016-09-21
00886333001408Skin Fix8025000008025000002022-07-14
00886333217618Skater™ Fix8025000018025000012022-07-14
00886333226320Co-Axial Introducer NeedleMCXS1620BXMCXS1620BX2022-07-21
00886333000005SKATER™ Drainage Catheter751106025E7511060252022-07-11
00886333000012SKATER™ Drainage Catheter751106035E7511060352022-07-12
00886333000029SKATER™ Drainage Catheter751107025E7511070252022-07-12
00886333000036SKATER™ Drainage Catheter751107035E7511070352022-07-11
00886333000043SKATER™ Drainage Catheter751108025E7511080252022-07-11
00886333000067SKATER™ Drainage Catheter751110025E7511100252022-07-12
00886333000074SKATER™ Drainage Catheter751110035E7511100352022-07-12
00886333000081SKATER™ Drainage Catheter751112025E7511120252022-07-13
00886333000098SKATER™ Drainage Catheter751112035E7511120352022-07-12
00886333000104SKATER™ Drainage Catheter751114025E7511140252022-07-12
00886333000111SKATER™ Drainage Catheter755106025E7551060252022-07-13
00886333000128SKATER™ Drainage Catheter755106035E7551060352022-07-12
00886333000135SKATER™ Drainage Catheter755107025E7551070252022-07-13
00886333000142SKATER™ Drainage Catheter755107035E7551070352022-07-12
00886333000159SKATER™ Drainage Catheter755108025E7551080252022-07-12
00886333000166SKATER™ Drainage Catheter 755108035E7551080352022-07-13

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