FDA.reportPublic FDA data

FENTEX

Primary DI
04250407707989
Brand
FENTEX
Company
FENTEX medical GmbH
Model
085416FX
Catalog number
085416FX
Device description
Artery Forceps by Rochester-Pean straight 16 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
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
04250407707989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407707989042504077079894250407707989

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
04250407788339FENTEX270263FX270263FX2025-12-30
04250407786847FENTEX540730FX540730FX2025-03-25
04250407786854FENTEX540732FX540732FX2025-03-25
04250407786861FENTEX540733FX540733FX2025-03-25
04250407786878FENTEX540734FX540734FX2025-03-25
04250407786885FENTEX540701FX540701FX2025-03-25
04250407786892FENTEX540702FX540702FX2025-03-25
04250407786908FENTEX540704FX540704FX2025-03-25
04250407778262FENTEX540780FX540780FX2025-02-19
04250407786663FENTEX118960FX118960FX2024-12-28
04250407786670FENTEX118970FX118970FX2024-12-28
04250407786731FENTEX540725FX540725FX2024-10-18
04250407786748FENTEX540726FX540726FX2024-10-18
04250407786755FENTEX540727FX540727FX2024-10-18
04250407786762FENTEX540728FX540728FX2024-10-18
04250407731571FENTEX363600FX363600FX2022-12-12
04250407731816FENTEX379100FX379100FX2022-12-12
04250407785116FENTEX540700FX540700FX2024-08-01
04250407785314FENTEX540705FX540705FX2024-08-01
04250407785321FENTEX540710FX540710FX2024-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800171Adler Instrument CompanyAdler, Inc.MDM2026-05-26
00810220800188Adler Instrument CompanyAdler, Inc.MDM2026-05-26
06438394002678Activa InstrumentBioretec OyMDM2026-03-23
06438394002685Activa InstrumentBioretec OyMDM2026-03-23
06438394002692Activa InstrumentBioretec OyMDM2026-03-23
06438394020382Activa InstrumentBioretec OyMDM2026-03-23
06438394010956Activa InstrumentBioretec OyMDM2026-03-23
00198506089619ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-17
00888867519459Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519473Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519503Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519510Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529755Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529793Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529823Arthrex®ARTHREX, INC.MDM2026-03-16
00198506089510ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-13
00810158219236PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219243PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219250PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219281PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219304PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219311PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219359PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219373PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219007PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219014PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219021PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219038PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219069PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219090PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11