FDA.reportPublic FDA data

BD QUINCKE Spinal Needles

Primary DI
00382904001063
Brand
BD QUINCKE Spinal Needles
Company
BECTON, DICKINSON AND COMPANY
Model
400106
Catalog number
400106
Device description
NEEDLE SPINAL S/SU 23GA 3-1/2IN QUINCKE
Published
2016-09-16
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

Product Codes#

Code, Name table
CodeName
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904001064PackageGS125In Commercial Distribution
50382904001068PackageGS14In Commercial Distribution
00382904001063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290400106430382904001064
5038290400106850382904001068
00382904001063003829040010633829040010630382904001063

GMDN Terms#

Term, Definition table
TermDefinition
Spinal needle, single-useA sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device.

Regulatory Flags#

DUNS number
001292192
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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