FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF4631917HZU0
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
46.319.17HZU
Catalog number
46.319.17HZU
Device description
SCISSORS, SURGICAL TISSUE, MICRO MICRO-SPRING SCISSORS, DESIGN HÜRZELER/ZUHR, CURVED,
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
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF4631917HZU0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. 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
G879103050TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103052SC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103062TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103065TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030900DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030920DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030930DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103107TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103113TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103116TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103118TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031230DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879GTC130DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
B382SD903260120Surgical DirectSurgical Direct, Inc.EGN2026-09-29
G8791030490DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-08-23