FDA.report

Kirwan

Primary DI
00841019120422
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
26-2520S
Device description
Round Weighted Foot Pedal Increased Working Length (Special)
Published
2021-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841019120422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841019120422008410191204228410191204220841019120422

GMDN Terms

TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Device Sizes

TypeValueUnit
Length12Feet

Sterilization Methods

Method

Contacts

PhoneEmail
781-834-9500mprario@ksp.com

Regulatory Flags

DUNS number
046355210
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841019123799Kirwan12-1633AUS2026-02-20
00841019123706Kirwan10-3442AUS2026-02-11
00841019123676Kirwan20-1620AUS2026-02-07
00841019123683Kirwan10-5603AUS2026-01-31
00841019123690Kirwan10-5603AUS2026-01-31
00841019123669Kirwan12-1432AUS2026-01-29
00841019123614Kirwan10-1403AUS2025-12-24
00841019123621Kirwan20-1413EAUS2025-11-14
00841019123003Kirwan22-1632PL2025-09-27
00841019123584Kirwan12-1633AUS2025-09-11
00841019123607Kirwan14-7000S2025-09-04
00841019123454Kirwan21-1409AUS2025-09-03
00841019123461Kirwan21-1413AUS2025-09-03
00841019123478Kirwan21-1417AUS2025-09-03
00841019123485Kirwan21-1421AUS2025-09-03
00841019123492Kirwan24-1430AUS2025-09-03
00841019123515Kirwan10-5404NSS2025-09-03
00841019123539Kirwan15-5303S2025-09-03
00841019123522Kirwan15-5303S2025-08-29
00841019123416Kirwan12-1637AUS2025-08-02

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00653405013924CONMEDConmed CorporationGEI2026-03-23
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10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
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08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD8800290Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD881190Surgical DirectSurgical Direct, Inc.GEI2026-03-09