FDA.reportPublic FDA data

Axon

Primary DI
00841019109281
Brand
Axon
Company
Axon Medical Inc
Model
J1000
Device description
"8 1/2"" Hardy Bayonet Forceps Insulated, with Stops, 0.5mm Tip"
Published
2016-07-20
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811820000BIPOLAR COAGULATING FORCEPSNew England Surgical Instrument Corp.1981-07-28GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841019109281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841019109281008410191092818410191092810841019109281

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length8.5Inch

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
111700451
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841019109243AxonJHO-012016-07-20
00841019109250AxonJHO-022016-07-20
00841019109267AxonJHO-032016-07-20
00841019109274AxonJHO-042016-07-20
00841019109298AxonJ10202016-07-20
00841019109304AxonJ20752016-07-20
00841019109311AxonJ20852016-07-20
00841019109328AxonL40202016-07-20
00841019109335AxonP03562016-07-20
00841019109342AxonP10072016-07-20
00841019109359AxonP10102016-07-20
00841019109366AxonP33002016-07-20
00841019109373AxonRAY-012016-07-20
00841019109380AxonRAY-032016-07-20
00841019109397AxonRAY-052016-07-20
00841019109403AxonRAY-072016-07-20
00841019109410AxonRAY-512016-07-20
00841019109427AxonRAY-532016-07-20
00841019109434AxonRAY-552016-07-20

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Primary DI, Brand, Company table
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