FDA.reportPublic FDA data

Uterine Manipulator / Injector 4,5mm

Primary DI
05051223000600
Brand
Uterine Manipulator / Injector 4,5mm
Company
PURPLE SURGICAL INTERNATIONAL LIMITED
Model
PS3111
Catalog number
PS3111
Device description
The Uterine manipulator/Injector both a Uterine Manipulator and a Uterine Injector with application in Diagnostic Laparoscopy, Minilaparotomy, Fertility Examinations and salpingoplastics.
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
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35051223000601PackageGS110In Commercial Distribution
55051223000605PackageGS140In Commercial Distribution
05051223000600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3505122300060135051223000601
5505122300060555051223000605
05051223000600050512230006005051223000600

GMDN Terms#

Term, Definition table
TermDefinition
Salpingographic catheterA flexible, balloon-tipped tube inserted transvaginally and through the uterus for the selective catheterization/cannulation of the fallopian tubes, in order to inject dye or a contrast medium into the tubes for a radiographic procedure; it is usually radiopaque. This is a single-use device.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30859500005005FemVueFEMASYS INC.LKF2026-01-06
00888937029697ALLY II UPS (Uterine Positioning System)Coopersurgical, Inc.LKF2025-12-18
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
00198506017704ELMED INCORPORATEDELMED INCORPORATEDLKF2025-07-08
00860010540930Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
10860010540937Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
00840306835360Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
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00840306835407Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835544Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
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04719894432571BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432588BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432595BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432601BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432618BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432625BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432755BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432762BiotequeBioteque Taiwan Ltd.LKF2024-04-08