FDA.reportPublic FDA data

FENTEX

Primary DI
04250407714130
Brand
FENTEX
Company
FENTEX medical GmbH
Model
137102FX
Catalog number
137102FX
Device description
Bone Rongeur by Citelli through-cutting WL 8 cm, size 2
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
04250407714130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407714130042504077141304250407714130

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. 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
04250407714147FENTEX137103FX137103FX2022-12-08
04250407714192FENTEX142100FX142100FX2022-12-08
04250407714208FENTEX142101FX142101FX2022-12-08
04250407714215FENTEX142102FX142102FX2022-12-08
04250407714222FENTEX142103FX142103FX2022-12-08
04250407714314FENTEX142120FX142120FX2022-12-08
04250407714369FENTEX142130FX142130FX2022-12-08
04250407714581FENTEX143101FX143101FX2022-12-08
04250407714598FENTEX143102FX143102FX2022-12-08

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
00198506091612ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00198506091629ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00810158211179PRINCETONPrinceton Medical Group, Inc.MDM2026-06-23
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08717903490617Humeca MAX Carrier 1:1 Humeca B.V.MDM2026-03-31