FDA.report

Kirwan

Primary DI
00841019104149
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
15-5404AU
Device description
Non-Stick Bipolar Coagulation Forceps 8 3/4" (22.2cm) Insulated Bayonet with Stop, Angled Up 0.5mm Tip
Published
2016-05-10
Public version status
Update
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
00841019104149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841019104149008410191041498410191041490841019104149

GMDN Terms

TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.

Device Sizes

TypeValueUnit
Length8.75Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
781-834-9500kprario@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
true

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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B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD8800290Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD881190Surgical DirectSurgical Direct, Inc.GEI2026-03-09