FDA.reportPublic FDA data

AccuTip

Primary DI
00817781020260
Brand
AccuTip
Company
CLINT PHARMACEUTICALS, INC.
Model
AT1835T
Device description
Fixed Wing Epidural Needle
Published
2016-12-28
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
10817781020267PackageGS125In Commercial Distribution
20817781020264PackageGS14In Commercial Distribution
00817781020260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081778102026710817781020267
2081778102026420817781020264
00817781020260008177810202608177810202600817781020260

GMDN Terms#

Term, Definition table
TermDefinition
Epidural needle, non-threadedA sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.5Inch
Needle Gauge18Gauge

Regulatory Flags#

DUNS number
609197785
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817781020000AccuTipAT2260C2016-12-28
00817781020017AccuTip AT1835Q2016-12-28
00817781020024AccuTipAT1860Q2016-12-28
00817781020031AccuTip AT2035Q2016-12-28
00817781020048AccuTip AT2060Q2016-12-28
00817781020055AccuTip AT2225Q2016-12-28
00817781020062AccuTip AT2230Q2016-12-28
00817781020079AccuTip AT2235Q2016-12-28
00817781020086AccuTip AT2250QS2016-12-28
00817781020093AccuTip AT2260QS2016-12-28
00817781020109AccuTip AT2270Q2016-12-28
00817781020116AccuTip AT2335Q2016-12-28
00817781020123AccuTipAT2350Q2016-12-28
00817781020130AccuTip AT2360Q2016-12-28
00817781020147AccuTip AT2525Q2016-12-28
00817781020154AccuTip AT2535Q2016-12-28
00817781020161AccuTip AT2550Q2016-12-28
00817781020178AccuTip AT2560Q2016-12-28
00817781020185AccuTip AT2570Q2016-12-28
00817781020192AccuTip AT1760T2016-12-28

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Primary DI, Brand, Company table
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