FDA.reportPublic FDA data

Codman

Primary DI
20886704072505
Brand
Codman
Company
SYNERGETICS USA, INC.
Model
80-7613
Catalog number
80-7613
Device description
"Disposable Spetzler™-Malis® ""Slim"" Bipolar Forceps, Bayonet, 9"" (23cm), 0.5mm Tip, Insulated, Non-Stick"
Published
2016-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886704072505PrimaryGS10
10886704072508Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670407250520886704072505
1088670407250810886704072508

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, single-useA sterile 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 single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021056726
Device count
5
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841305101118Synergetics18067180672020-09-18
10841305101064Synergetics18060180602020-05-31
10841305101071Synergetics18061180612020-05-31
10841305101088Synergetics18063180632020-05-31
10841305101095Synergetics18064180642020-05-31
10841305101125Synergetics18069180692020-05-31
10841305101132Synergetics18069W18069W2020-05-31
10841305101156Synergetics31.0231.022020-09-18
10841305101163Synergetics41.0041.002020-09-18
10841305101231Synergetics16579165792020-09-18
10841305101255Synergetics12.06.2512.06.252020-09-18
10841305101309Synergetics17570175702017-12-30
10841305101316Synergetics17580175802020-09-18
10841305101323Synergetics17680176802020-09-18
10841305101330Synergetics19020190202020-09-18
10841305101415Synergetics30.08.2330.08.232020-09-18
10841305101422Synergetics30.08.2530.08.252020-09-18
10841305101439Synergetics30.08.2730.08.272020-09-18
10841305101446Synergetics30.1030.102020-09-18
10841305101453Synergetics30.10.2330.10.232020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327693287MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693294MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693362MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693379MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693386MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693393MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693409MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693423MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693430MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693447MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693454MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693461MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693478MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693485MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693492MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693508MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693515MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693522MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693539MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693546MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693553MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693560MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548167NeptuneSTRYKER CORPORATIONGEI2024-12-10