FDA.reportPublic FDA data

Ultimate Dilating trocar with smooth cannula plus extra cannula

Primary DI
55051223015210
Brand
Ultimate Dilating trocar with smooth cannula plus extra cannula
Company
PURPLE SURGICAL INTERNATIONAL LIMITED
Model
PS4463ULT
Catalog number
PS4463ULT
Device description
The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
Published
2016-09-17
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

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
35051223015216PackageGS15In Commercial Distribution
55051223015210PackageGS120In Commercial Distribution
05051223015215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3505122301521635051223015216
5505122301521055051223015210
05051223015215050512230152155051223015215

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
239403863
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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