FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF2282016W0
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
22.820.16W
Catalog number
22.820.16W
Device description
PLIERS OPERATIVE, MICRO-DRESSING-FORCEPS 16CM, ZEPF-LINE LONG HANDLE,WITH GUIDANCE PIN
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJYPliers, operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJYPliers, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF2282016W0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. 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
+49742498880info@zepf-dental.com

Regulatory Flags#

DUNS number
320001431
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EZPF2305412HZU0HELMUT ZEPF23.054.12HZU23.054.12HZU2025-03-10
EZPF33750010HELMUT ZEPF33.750.0133.750.012025-03-10
EZPF3375001F0HELMUT ZEPF33.750.01F33.750.01F2025-03-10
EZPF33750020HELMUT ZEPF33.750.0233.750.022025-03-10
EZPF33760020HELMUT ZEPF33.760.0233.760.022025-03-10
EZPF33760030HELMUT ZEPF33.760.0333.760.032025-03-10
EZPF33760110HELMUT ZEPF33.760.1133.760.112025-03-10
EZPF33760200HELMUT ZEPF33.760.2033.760.202025-03-10
EZPF33760210HELMUT ZEPF33.760.2133.760.212025-03-10
EZPF1704503HZU0HELMUT ZEPF17.045.03HZU17.045.03HZU2025-03-07
EZPF1742301HZU0HELMUT ZEPF17.423.01HZU17.423.01HZU2025-03-07
EZPF1742302HZU0HELMUT ZEPF17.423.02HZU17.423.02HZU2025-03-07
EZPF2474403LM5HZU0HELMUT ZEPF24.744.03LM5-HZU24.744.03LM5-HZU2025-03-07
EZPF2474405GHZU0HELMUT ZEPF24.744.05G-HZU24.744.05G-HZU2025-03-07
EZPF2474408HZU0HELMUT ZEPF24.744.08HZU24.744.08HZU2025-03-07
EZPF2474411GHZU0HELMUT ZEPF24.744.11G-HZU24.744.11G-HZU2025-03-07
EZPF2474413GHZU0HELMUT ZEPF24.744.13G-HZU24.744.13G-HZU2025-03-07
EZPF2474455HZU0HELMUT ZEPF24.744.55HZU24.744.55HZU2025-03-07
EZPF2474460HZU0HELMUT ZEPF24.744.60HZU24.744.60HZU2025-03-07
EZPF2474465HZU0HELMUT ZEPF24.744.65HZU24.744.65HZU2025-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898588840032PEAK 003ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840049PEAK 004ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840841121ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840902ELASTIC SETTERZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841244REPLACEMENTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841497TRIDENT CURTO MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841541TWEED OMEGA LOOP MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841602V BEND MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841657WEINGART MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841855117 PZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588842272117 IZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840223CONVENTIONAL LARGE LINGUALZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588840919CONVENTIONAL LINGUALZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588840964YARN SHORTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588841831CONVENTIONAL LINGUAL IOMZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588841954CUT SHORTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588843484YARN SHORTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588843521BILLER CHALLENGEZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588840070ABELL FOR PEDIATRIC DENTISTRYZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840155ANDREZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840858PARROT BEAKZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840872FLAT BEAKZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840889BILLER CHALLENGEZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588841756MODIFIED ANDREZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588841763301 AIG 301ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588841770AIG 401ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588843132ALIGNER ACTIVATOR AND RETAINERZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840087MUSIC PLIER 2ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-01-05
07898588840094MUSIC PLIERS 2000ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-01-05
07898588840100MUSIC PLIERS 2001ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-01-05