Device
Disposable Bipolar Suction Coagulator 5 1/2" (14cm) 15 Fr Curved
Manufacturer
KIRWAN SURGICAL PRODUCTS LLC
KIRWAN SURGICAL PRODUCTS LLC
Model: 14-9020
DI: 00841019123881
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Disposable Bipolar Suction Coagulator 5 1/2" (14cm) 15 Fr Curved
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bbabf414-bed5-4b14-9ef6-5becc92cdaea
Distribution Status:
In Commercial Distribution
DUNS Number:
046355210
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
10841019123888
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00841019123881
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00841019123881
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
20841019123885
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
25
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00841019123881
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 56296
Name: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Definition:
A sterile 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 single-use device.
FDA Product Codes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
Premarket Submissions
Submission Number:
K960455
Supplement Number:
000