FDA.reportPublic FDA data

Titan

Primary DI
00817914020167
Brand
Titan
Company
TITAN MANUFACTURING INC
Model
160910205020401
Device description
"Iris Angled Bipolar Forcep 3 1/2"" (88.9mm) With A With A 0.4mm Tip"
Published
2017-03-31
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
K974594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974594000SEMKIN BIPOLAR FORCEPTitan Mfg., Inc.1998-06-24HTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817914020167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817914020167008179140201678179140201670817914020167

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
Length3.5Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6109358203stephaniem@titanmfg.com
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
00817914020174Titan1609102050301012017-03-31
00817914020181Titan1609102061301012017-03-31
00817914020198Titan1609182050304012017-03-31
00817914020204Titan1609182051304012017-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092978ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092985ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092992ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093340ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093449ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093456ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
10884450452360STAR™Merit Medical Systems, Inc.GEI2026-07-28