FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF19710180
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
19.710.18
Catalog number
19.710.18
Device description
SYRINGE, CARTRIDGE BREECH LOADING SYSTEM, WITH 3 ASPIRAT. WITH 3 ASPIRATION HOOKS , 1.8 ML
Published
2022-11-30
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
ECBUNIT, SYRINGE, AIR AND/OR WATER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF19710180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia syringe, reusableA hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. 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
30810021439403DCIDCI International, LLCECB2025-11-19
00840326423677AstekYoung Innovations, Inc.ECB2025-02-07
TQ26SYT253721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.ECB2024-12-09
D248B16201DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B16211DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B1629C1Uni-TipHAGER WORLDWIDE, INC.ECB2024-05-20
00810339031176SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031251SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031374SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003577SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003607SAFE DENTBGSS Company Inc.ECB2024-05-01
00840326421994AstekYoung Innovations, Inc.ECB2023-12-01
00840326422007AstekYoung Innovations, Inc.ECB2023-12-01
00840326422014AstekYoung Innovations, Inc.ECB2023-12-01
00840326422021AstekYoung Innovations, Inc.ECB2023-12-01
00840326422045AstekYoung Innovations, Inc.ECB2023-12-01
00840326422052AstekYoung Innovations, Inc.ECB2023-12-01
00840326422069AstekYoung Innovations, Inc.ECB2023-12-01
00840326422076AstekYoung Innovations, Inc.ECB2023-12-01
00840326422083AstekYoung Innovations, Inc.ECB2023-12-01
00840326422090AstekYoung Innovations, Inc.ECB2023-12-01
00840326422106AstekYoung Innovations, Inc.ECB2023-12-01
00840326422113AstekYoung Innovations, Inc.ECB2023-12-01
D248B16291Uni-Tip -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16311Access-Tips -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16331Uni-Tip -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16341Access-Tips -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16351Uni-Tip -Package of 25HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16361Access-Tips -Package of 25HAGER WORLDWIDE, INC.ECB2023-09-12
D248BOA124P10001Uni-Tip -Package of 5HAGER WORLDWIDE, INC.ECB2023-09-12