FDA.reportPublic FDA data

Kirwan

Primary DI
00841019107287
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
30-3012
Device description
"Reusable Monopolar Forceps 7"" (17.5cm) Potts-Smith, Insulated, Serrated 2mm Tip"
Published
2016-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872271000VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPSNew England Surgical Instrument Corp.1987-06-26GEN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841019107287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841019107287008410191072878410191072870841019107287

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, reusableAn invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-834-9500kprario@ksp.com
781-834-9500mprario@ksp.com

Regulatory Flags#

DUNS number
046355210
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841019123928Kirwan21-1418AUS2026-08-22
00841019123713Kirwan22-1436PL2026-08-19
00841019123720Kirwan22-1446PL2026-08-19
00841019123737Kirwan22-1456PL2026-08-19
00841019123744Kirwan22-1466PL2026-08-19
00841019124154Kirwan10-1403AUS2026-08-19
00841019123898Kirwan21-1418AUS2026-08-18
00841019123935Kirwan21-1406AUS2026-08-07
00841019123942Kirwan21-1418AUS2026-08-07
00841019123867Kirwan12-1400AUS2026-07-24
00841019123959Kirwan12-1237NSS2026-07-25
00841019123966Kirwan12-1237NSS2026-07-25
00841019123973Kirwan12-1237NSS2026-07-25
00841019123980Kirwan12-1237NSS2026-07-25
00841019123997Kirwan12-1237NSS2026-07-25
00841019123836Kirwan20-1417NSS2026-05-13
00841019123881Kirwan14-90202026-05-01
00841019123812Kirwan10-2202NSS2026-04-14
00841019123829Kirwan10-2202NSS2026-04-14
00841019123799Kirwan12-1633AUS2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429034MillenniumAvalign Technologies, Inc.GEN2026-09-04
00190776429058MillenniumAvalign Technologies, Inc.GEN2026-09-04
04058749001280NAFehling Instruments GmbH & Co. KGGEN2026-09-04
00190776427993MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776428167MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776427559MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427665MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427740MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427764MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427771MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427788MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427795MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776420369MillenniumAvalign Technologies, Inc.GEN2026-08-25
00190776418236MillenniumAvalign Technologies, Inc.GEN2026-08-23
00190776427238MillenniumAvalign Technologies, Inc.GEN2026-08-21
00190776427269MillenniumAvalign Technologies, Inc.GEN2026-08-21
00190776427276MillenniumAvalign Technologies, Inc.GEN2026-08-21
B382SD914775290Surgical DirectSurgical Direct, Inc.GEN2026-08-21
00190776417727MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776426767MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776417109MillenniumAvalign Technologies, Inc.GEN2026-08-18
00198506094002ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00198506094057ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00190776425838MillenniumAvalign Technologies, Inc.GEN2026-08-17
G453333630140PEAK MEDICALPeak Medical Distribution Inc.GEN2026-08-14
00190776423544MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776423735MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776424404MillenniumAvalign Technologies, Inc.GEN2026-08-07
B382SD9238971100Surgical DirectSurgical Direct, Inc.GEN2026-08-07
00190776408763MillenniumAvalign Technologies, Inc.GEN2026-08-03