FDA.reportPublic FDA data

FENTEX

Primary DI
04250407719081
Brand
FENTEX
Company
FENTEX medical GmbH
Model
176814FX
Catalog number
176814FX
Device description
Scissors by Joseph straight, with tungsten carbide inserts 14 cm
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04250407719081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407719081042504077190814250407719081

GMDN Terms#

Term, Definition table
TermDefinition
Suture scissorsA hand-held surgical instrument used during surgery to cut suture or ligature material, i.e., to divide lengths or remove excessive/unwanted ends. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically metallic and is available in various designs and sizes; the blades may have different shapes, e.g., they can be curved or straight with a hook-like tip to capture the suture/ligature as it is cut. It is not a dedicated ophthalmic device. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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

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Primary DI, Brand, Company table
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00850088713046PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713053PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
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