Ion Coagulation Pen

Primary DI
B9122023152
Brand
Ion Coagulation Pen
Company
ION MEDICAL, INC.
Model
202315
Device description
20-23 Gauge Fine Point Bipolar Coagulation Pen
Published
2020-06-08
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072911000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072911000ION MEDICAL BIPOLAR COAGULATION PENIon Medical, LLC2007-12-13GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B9122023152PrimaryHIBCC0
B9122023151Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-785-7202sales@ionsurgical.com

Regulatory Flags#

DUNS number
020795679
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B9122018502Ion Coagulation Pen2018502020-06-08
B9122018602Ion Coagulation Pen2018602020-06-08
B9122020102Ion Coagulation Pen2020102020-06-08
B9122023102Ion Coagulation Pen2023102020-06-08
B9122023162Ion Coagulation Pen2023162020-06-08
B9122025302Ion Coagulation Pen2025302020-06-08
B9122027302Ion Coagulation Pen2027302020-06-08

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