FDA.reportPublic FDA data

Kirwan

Primary DI
00841019122488
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
41-9036
Device description
Disposable Monopolar Suction Nerve Stimulator, 10 French, 13cm Working Length
Published
2025-02-22
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
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100912000DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDEKirwan Surgical Products, Inc.2010-08-19GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019122485PackageGS15In Commercial Distribution
20841019122482PackageGS125In Commercial Distribution
00841019122488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101912248510841019122485
2084101912248220841019122482
00841019122488008410191224888410191224880841019122488

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.

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

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00816312028614Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-08
00816312028621Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-08
10816312028673Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-09-21
05707480167579Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
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05707480167609Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167630Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167661Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
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08718375866672Neurosign V4Technomed Engineering B.V.GXZ2020-07-22
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