FDA.reportPublic FDA data

Kirwan

Primary DI
00841019119105
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
30-8004
Device description
"5 1/2"" Insulated Straight Micro Dissection Needle"
Published
2021-02-23
Public version status
New
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
JOSElectrode, Electrosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOSElectrode, ElectrosurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895331000ELECTROSURGICAL ELECTRODENew England Surgical Instrument Corp.1989-09-15JOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019119102PackageGS15In Commercial Distribution
00841019119105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101911910210841019119102
00841019119105008410191191058410191191050841019119105

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/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 single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.5Inch

Contacts#

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

Regulatory Flags#

DUNS number
046355210
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841019124192Kirwan10-1413AUS2026-10-21
00841019124017Kirwan21-1410AUS2026-10-16
00841019124024Kirwan21-1412AUS2026-10-16
00841019124048Kirwan21-1445AUS2026-10-16
00841019124079Kirwan21-1446AUS2026-10-16
00841019124086Kirwan21-1422AUS2026-10-16
00841019124093Kirwan21-1424AUS2026-10-16
00841019124109Kirwan21-1425AUS2026-10-16
00841019124116Kirwan21-1447AUS2026-10-16
00841019124123Kirwan21-1426AUS2026-10-16
00841019124130Kirwan21-1428AUS2026-10-16
00841019124000Kirwan21-1443AUS2026-09-19
00841019124055Kirwan21-1420AUS2026-09-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800142924491OsteoBlate™RF Medical Co.,Ltd.JOS2026-10-13
08809295141007BIG-TIP™ RF Medical Co.,Ltd.JOS2025-09-05
08800142925092THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925108THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925115THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925122THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
04050147022751ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022768ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022775ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022782ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023543ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023550ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023567ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023574ErbeErbe Elektromedizin GmbHJOS2025-01-21
00821925008083BovieGyrus ACMI, LLCJOS2024-07-25
00821925008458BovieGyrus ACMI, LLCJOS2024-07-25
00845854030632CONMEDConmed CorporationJOS2023-12-05
08800142919206THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919213THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919220THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08809295147382V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147399V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147405V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147412V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147429V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147436V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147443V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147450V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147467V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147474V-TipRF Medical Co.,Ltd.JOS2023-10-24