FDA.reportPublic FDA data

Titan

Primary DI
00817914020761
Brand
Titan
Company
TITAN MANUFACTURING INC
Model
162428237060101
Device description
"Gerald Bayonet Bipolar Forcep 7 1/2"" (190.5mm) Insulated With A With A 1.0mm Tip Anti-Stick"
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K974593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974593000SEMKIN INSULATED BIPOLAR FORCEPTitan Mfg., Inc.1998-06-24HTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817914020761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817914020761008179140207618179140207610817914020761

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.5Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6109358203don@titanmfg.com

Regulatory Flags#

DUNS number
011642563
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817914020006Titan1601182110201012017-03-31
00817914020013Titan1602102090201012017-03-31
00817914020020Titan1602102090208012017-03-31
00817914020037Titan1602102090212012017-03-31
00817914020044Titan1602182090201012017-03-31
00817914020051Titan1602182090212012017-03-31
00817914020068Titan1603102150208012017-03-31
00817914020075Titan1605101090201012017-03-31
00817914020082Titan1606102150601012017-03-31
00817914020099Titan1606182150601012017-03-31
00817914020105Titan1606282150601012017-03-31
00817914020112Titan1607182170601012017-03-31
00817914020129Titan1608102050201012017-03-31
00817914020136Titan1608102050301012017-03-31
00817914020143Titan1608182051301012017-03-31
00817914020150Titan1608202061301012017-03-31
00817914020167Titan1609102050204012017-03-31
00817914020174Titan1609102050301012017-03-31
00817914020181Titan1609102061301012017-03-31
00817914020198Titan1609182050304012017-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
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00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
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00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
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00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03