FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF2474470HZU0
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
24.744.70HZU
Catalog number
24.744.70HZU
Device description
BACK-ACTION CHISEL 4MM/5MM COMBO DOUBLE ENDED HUERZELER/ZUHR DESIGN HANDLE, TIPS EXCHANGEABLE
Published
2022-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF2474470HZU0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gougeA heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49742498880info@zepf-dental.com

Regulatory Flags#

DUNS number
320001431
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EZPF2423001G0HELMUT ZEPF24.230.01G24.230.01G2026-04-13
EZPF2423001GM50HELMUT ZEPF24.230.01GM524.230.01GM52026-04-13
EZPF2423103G0HELMUT ZEPF24.231.03G24.231.03G2026-04-13
EZPF2423105G0HELMUT ZEPF24.231.05G24.231.05G2026-04-13
EZPF2423105GM50HELMUT ZEPF24.231.05GM524.231.05GM52026-04-13
EZPF2423105L0HELMUT ZEPF24.231.05L24.231.05L2026-04-13
EZPF2423411G0HELMUT ZEPF24.234.11G24.234.11G2026-04-13
EZPF2423411GM50HELMUT ZEPF24.234.11GM524.234.11GM52026-04-13
EZPF2423415G0HELMUT ZEPF24.234.15G24.234.15G2026-04-13
EZPF2423507G0HELMUT ZEPF24.235.07G24.235.07G2026-04-13
EZPF2423507GM50HELMUT ZEPF24.235.07GM524.235.07GM52026-04-13
EZPF2423609G0HELMUT ZEPF24.236.09G24.236.09G2026-04-13
EZPF2423713G0HELMUT ZEPF24.237.13G24.237.13G2026-04-13
EZPF2423713GM50HELMUT ZEPF24.237.13GM524.237.13GM52026-04-13
EZPF2423717G0HELMUT ZEPF24.237.17G24.237.17G2026-04-13
EZPF2423803L0HELMUT ZEPF24.238.03L24.238.03L2026-04-13
EZPF2423804S0HELMUT ZEPF24.238.04S24.238.04S2026-04-13
EZPF2423804SD0HELMUT ZEPF24.238.04SD24.238.04SD2026-04-13
EZPF2423806HF0HELMUT ZEPF24.238.06HF24.238.06HF2026-04-13
EZPF2423823A0HELMUT ZEPF24.238.23A24.238.23A2026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879OSTCVC220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
04099797012989SCREW-LINE Osteotomy setALTATEC GmbHEMM2026-08-17
04099797012996SCREW-LINE Osteotomy setALTATEC GmbHEMM2026-08-17
04099797013016SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013047SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013078SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013108SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013139SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013153SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013184SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013214SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17