FDA.report

Adult Lumbar Puncture Tray

Primary DI
20886333222913
Brand
Adult Lumbar Puncture Tray
Company
ARGON MEDICAL DEVICES, INC.
Model
A4301CSP
Catalog number
A4301CSP
Device description
Adult Lumbar Puncture Tray with Safety Devices and 20ga x 8.9cm Spinal Needle
Published
2016-09-15
Public version status
Update
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
OGJNerve Block Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20886333222913PackageGS110In Commercial Distribution
00886333222919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633322291320886333222913
00886333222919008863332229198863332229190886333222919

GMDN Terms

TermDefinition
Lumbar puncture kitA collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags

DUNS number
140727624
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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