Kirwan (Nidek)

GUDID 20841019116627

Disposable Bipolar Pencil 25 Gauge Straight

KIRWAN SURGICAL PRODUCTS LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Primary Device ID20841019116627
NIH Device Record Keyed671e19-ef1c-4e55-9004-1b354b89a5ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameKirwan (Nidek)
Version Model Number18241-0979
Company DUNS046355210
Company NameKIRWAN SURGICAL PRODUCTS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-834-9500
Emailmprario@ksp.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841019116623 [Primary]
GS110841019116620 [Package]
Contains: 00841019116623
Package: [5 Units]
In Commercial Distribution
GS120841019116627 [Package]
Contains: 00841019116623
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20841019116627]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-17

On-Brand Devices [Kirwan (Nidek)]

20841019116627Disposable Bipolar Pencil 25 Gauge Straight
20841019116610Disposable Bipolar Pencil 23 Gauge Straight

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