Arms Medical SEP2A

GUDID G373SEP2A0

Smoke-Evacuation Electrosurgical Pencil

Zinnanti Surgical Design Group Inc

Electrosurgical handpiece, single-use
Primary Device IDG373SEP2A0
NIH Device Record Key1638a596-8ade-42fe-b024-74193aef358c
Commercial Distribution StatusIn Commercial Distribution
Brand NameArms Medical
Version Model NumberSEP2A
Catalog NumberSEP2A
Company DUNS078579514
Company NameZinnanti Surgical Design Group Inc
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG373SEP2A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-08
Device Publish Date2022-10-31

Devices Manufactured by Zinnanti Surgical Design Group Inc

G373144051ESU0 - Zinnanti Surgical2024-12-19 Smoke Evac Sterile Derm Adapter Kit Bovie
G3731440140 - Zinnanti Surgical2024-10-17 Suction Connector 8' SEF Tubing Kit- Non Sterile
G373144051DHB0 - Zinnanti Surgical2024-09-23 Smoke Evac Derm Adapter Kit-Bovie
G373144005J0 - Zinnanti Surgical2024-09-04 J-Tip Biopsy Cartridge
G3731440150 - Zinnanti Surgical2024-09-02 SEF Suction Tubing Kit For Fluid Catch
G373144017HB0 - Zinnanti Surgical 2024-09-02 Suction Tubing Kit Fluid Catch For Bovie
G3731401100 - Zinnanti Surgical2024-08-22 6" Smoke Evac Fusion 15mm x 23mm Sail Loop
G3731401150 - Zinnanti Surgical2024-08-22 6" Smoke Evac Fusion 11mm x 18mm Sail Loop

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