FDA.reportPublic FDA data

FENTEX

Primary DI
04250407710941
Brand
FENTEX
Company
FENTEX medical GmbH
Model
112214FX
Catalog number
112214FX
Device description
Operating Scissors by Mayo curved 14.5 cm
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250407710941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407710941042504077109414250407710941

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4974679496212s.renner@fentexmedical.com

Regulatory Flags#

DUNS number
507221724
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250407712549FENTEX120202FX120202FX2022-12-08
04250407712556FENTEX120203FX120203FX2022-12-08
04250407712563FENTEX120204FX120204FX2022-12-08
04250407712570FENTEX120206FX120206FX2022-12-08
04250407712587FENTEX120208FX120208FX2022-12-08
04250407712594FENTEX120210FX120210FX2022-12-08
04250407713577FENTEX135100FX135100FX2022-12-08
04250407713584FENTEX135101FX135101FX2022-12-08
04250407713591FENTEX135102FX135102FX2022-12-08
04250407713607FENTEX135103FX135103FX2022-12-08
04250407714123FENTEX137101FX137101FX2022-12-08
04250407714130FENTEX137102FX137102FX2022-12-08
04250407714147FENTEX137103FX137103FX2022-12-08
04250407714192FENTEX142100FX142100FX2022-12-08
04250407714208FENTEX142101FX142101FX2022-12-08
04250407714215FENTEX142102FX142102FX2022-12-08
04250407714222FENTEX142103FX142103FX2022-12-08
04250407714314FENTEX142120FX142120FX2022-12-08
04250407714369FENTEX142130FX142130FX2022-12-08
04250407714581FENTEX143101FX143101FX2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9176201020Surgical DirectSurgical Direct, Inc.MDM2026-07-13
03661219436348LANDANGERLANDANGERMDM2026-07-12
00810158210615PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00810158215917PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713015PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713039PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713046PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713053PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
03661219436706LANDANGERLANDANGERMDM2026-07-08
04054462915583evonosevonos GmbH & Co. KGMDM2026-06-25
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00810158211179PRINCETONPrinceton Medical Group, Inc.MDM2026-06-23
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
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