FDA.reportPublic FDA data

Ultimate Monopolar Intestinal Forceps

Primary DI
35051223006153
Brand
Ultimate Monopolar Intestinal Forceps
Company
PURPLE SURGICAL INTERNATIONAL LIMITED
Model
PS3587ULT
Catalog number
PS3587ULT
Device description
The Forceps are for use during a variety of laparoscopic procedures for cutting, grasping, coagulation & transaction of vessels & tissue.
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35051223006153PackageGS15In Commercial Distribution
05051223006152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3505122300615335051223006153
05051223006152050512230061525051223006152

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. 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
55051223000612Hasson TrocarPS3210PS32102016-09-17
55051223000629Hasson TrocarPS3212PS32122016-09-17
55051223000636Secondary Trocar with gas portPS3307PS33072016-09-17
55051223000704Auto-shield trocar, ribbed cannulaPS3510PS35102016-09-17
35051223000717Auto-shield trocar, ribbed cannulaPS3512PS35122016-09-17
50551223000742Auto-shield trocar, ribbed cannulaPS3515PS35152016-09-17
35051223003374Auto Shield Trocar Ribbed, plus extra cannula PS3518PS35182016-09-17
50551223003873Secondary Trocar with gas portPS3305PS33052016-09-17
55051223003880Secondary Trocar without gas portPS3306PS33062016-09-17
55051223003897Secondary Trocar with Gas Port + Additional Cannula without Gas PortPS3355PS33552016-09-17
55051223003903Secondary trocar without Gas Port + Additional Cannula without Gas PortPS3356PS33562016-09-17
55051223003910Dilating tip trocar, ribbedPS3410PS34102016-09-17
55051223003927Dilating tip trocar, ribbedPS3415PS34152016-09-17
55051223003972Auto-shield trocar, ribbed PS3505PS35052016-09-17
55051223003996Universal cannulaPS3507PS35072016-09-17
50551223004009Universal cannulaPS3508 PS35082016-09-17
35051223004012Auto-shield trocar, ribbed cannulas plus extra cannulasPS3509PS35092016-09-17
35051223004029Auto-shield trocar, ribbed cannula plus additional cannulaPS3513PS35132016-09-17
35051223004036Auto-shield trocar, ribbed cannula plus extra cannulaPS3514PS35142016-09-17
55051223004856Ultimate Auto-shield trocar with ribbed cannulaPS3560ULTPS3560ULT2016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850067560316LaproSacSurgical Principals, IncGEI2026-05-22
ESUM3644100SutterSutter Medizintechnik GmbHGEI2026-05-22
00845854035590CONCEPTConmed CorporationGEI2026-03-24
00190776417932MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776417956MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418076MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418281MillenniumAvalign Technologies, Inc.GEI2026-03-23
00653405013924CONMEDConmed CorporationGEI2026-03-23
00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
00198506089749ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108166DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108180DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108197DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108203DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108289DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108272DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108296DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108302DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108319DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108326DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108395POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108401POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108425POTENZAJeisys Medical Inc.GEI2026-03-16
00198506089565ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-13
10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
10884450587802STAR™Merit Medical Systems, Inc.GEI2026-03-11
08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09