Kirwan (Distributor Gyrus ACMI)

GUDID 00841019108765

Bipolar Semkin Forceps, Non-Stick Reusable 0.7mm Tips, Length 5.5"

KIRWAN SURGICAL PRODUCTS LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Primary Device ID00841019108765
NIH Device Record Keyf1aef540-2cac-41b7-8352-5c66a2dab873
Commercial Distribution StatusIn Commercial Distribution
Brand NameKirwan (Distributor Gyrus ACMI)
Version Model Number13-1505
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-834-9500
Emailkprario@ksp.com

Device Dimensions

Length5.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841019108765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841019108765]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-26

On-Brand Devices [Kirwan (Distributor Gyrus ACMI)]

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00841019108789Bipolar Bayonet Tonsil Forceps Non-Stick Insulated, Reusable 2mm Tips, Length 7.5"
00841019108772Bipolar Cushing Bayonet Forceps, Non-Stick Insulated, Reusable 0.7mm Tips, Length 7.5"
00841019108765Bipolar Semkin Forceps, Non-Stick Reusable 0.7mm Tips, Length 5.5"
00841019108758Bipolar Adson Forceps, Non-Stick Insulated, Reusable 1mm Tips, Length 5"
00841019108741Bipolar Adson Forceps Non-Stick Reusable 1mm Tips Length 5"
00841019108734Bipolar Iris Forceps, Non-Stick Curved Tips, Reusable 0.4mm Tips, Length 3.5"
00841019108727Bipolar Iris Forceps, Non-Stick Straight Tips, Reusable 0.4mm Tips, Length 3.5"

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