FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF47957600
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
47.957.60
Catalog number
47.957.60
Device description
CURETTE HANDLE ONLY, STRAIGHT, FOR BONE SCRAPER II /CURETTE Ø6
Published
2022-12-07
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
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF47957600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). 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
10653160384816CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2025-01-25
10653160382133CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-11-08
10653160382140CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-11-08
10653160374862CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-05-18
08806395489848PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
08806395489855PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
08806395489862PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
10653160357506CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2023-01-13
07898506841431QuinelatoSchobell Industrial LtdaHTF2023-01-10
07898506845439QuinelatoSchobell Industrial LtdaHTF2023-01-10
07898506848447QuinelatoSchobell Industrial LtdaHTF2023-01-10
07898506841929QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506841967QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506848935QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506848942QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506849260QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506849314QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506853793QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506853809QuinelatoSchobell Industrial LtdaHTF2023-01-09
EZPF41891040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-16
EZPF4185501ZS0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-08
10653160351368CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351382CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351399CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351429CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351474CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160307334CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-02
10653160278795CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01
10653160279846CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01
10653160279853CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01