FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF41853210
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
41.853.21
Catalog number
41.853.21
Device description
COMBI INSTRUMENT, BACK ACTION 90°, GLICKMAN KNIFE 4MM, BIONIK HANDLE LIGHTRED-MAGENTA
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
EMSCURETTE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF41853210PrimaryHIBCC0

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
G149TBSB5050TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5060TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5070TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5080TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5100TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5120TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5130TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5140TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5160TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5170TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5180TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5200TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5210TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5220TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5230TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5240TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5250TBS BASICSACME ENTERPRISE.EMS2026-05-20
EZPF2423001G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423001GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423103G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105L0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423411G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423411GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423415G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423507G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423507GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423609G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423713G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13