FDA.reportPublic FDA data

Veress Needle

Primary DI
05051223000808
Brand
Veress Needle
Company
PURPLE SURGICAL INTERNATIONAL LIMITED
Model
PS3750
Catalog number
PS3750
Device description
The Veress needle is used to establish a pneumoperitoneum prior to abdominal laparoscopic procedures.
Published
2016-09-17
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
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35051223000809PackageGS125In Commercial Distribution
55051223000803PackageGS1100In Commercial Distribution
05051223000808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3505122300080935051223000809
5505122300080355051223000803
05051223000808050512230008085051223000808

GMDN Terms#

Term, Definition table
TermDefinition
Spring-loaded pneumoperitoneum needle, single-useA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Millimeter

Contacts#

Phone, Email table
PhoneEmail
+441923839333mail@purplesurgical.com

Regulatory Flags#

DUNS number
239403863
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051223004684Ultimate Monopolar Straight Grasping Forceps with Ratchet PS3556ULTPS3556ULT2016-09-17
05051223004813Ultimate Monopolar Metzenbaum Scissor PS3551ULTPS3551ULT2016-09-17
05051223004820Ultimate Monopolar Maryland Dissecting Forceps PS3552ULTPS3552ULT2016-09-17
05051223004837Ultimate Monopolar Straight Grasping Forceps PS3553ULTPS3553ULT2016-09-17
05051223004844Ultimate Monopolar LapClinch with Ratchet PS3554ULTPS3554ULT2016-09-17
05051223005360Ultimate Monopolar scissorsPS3531ULTPS3531ULT2016-09-17
05051223005377Ultimate Maryland dissecting forcepsPS3532ULTPS3532ULT2016-09-17
05051223005384Ultimate Straight grasping forcepsPS3533ULTPS3533ULT2016-09-17
05051223005391Ultimate Lapclinch with ratchetPS3534ULTPS3534ULT2016-09-17
05051223005407Ultimate Straight grasping forceps with ratchetPS3536ULTPS3536ULT2016-09-17
05051223005414Ultimate Intestinal forceps with ratchet PS3537ULTPS3537ULT2016-09-17
05051223005421Ultimate Rat Tooth lapclinch with ratchetPS3538ULTPS3538ULT2016-09-17
05051223005438Ultimate BabcockPS3539ULTPS3539ULT2016-09-17
05051223005445Ultimate Monopolar Scissor PS3541ULTPS3541ULT2016-09-17
05051223005452Ultimate Maryland Dissecting Forceps PS3542ULTPS3542ULT2016-09-17
05051223005469Ultimate Straight Grasping Forceps PS3543ULTPS3543ULT2016-09-17
05051223005476Ultimate LapClinch with Ratchet PS3544ULTPS3544ULT2016-09-17
05051223005483Ultimate Straight Grasping Forceps with Ratchet PS3546ULTPS3546ULT2016-09-17
05051223005490Ultimate Intestinal Forceps with Ratchet PS3547ULTPS3547ULT2016-09-17
05051223005506Ultimate Rat Tooth LapClinch with Ratchet PS3548ULTPS3548ULT2016-09-17

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