FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF4131817TC0
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
41.318.17TC
Catalog number
41.318.17TC
Device description
HOLDER, NEEDLE LICHTENBERG-RYDER NEEDLE HOLDER 17 CM, SMOOTHLINE, TC, STR
Published
2022-12-07
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
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF4131817TC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
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

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Primary DI, Brand, Company table
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04059453049339Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-03-10
B382SD9056641000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
B382SD9056791000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
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B382SD905662170Surgical DirectSurgical Direct, Inc.FHQ2026-02-20
G4254202130My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202200My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202240My MedicalMy Medical Store LLCFHQ2026-02-17
B382SD905434160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD90548817LH0Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9055891110Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9056791160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9084551100Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
00192896122628Glasser Micro Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00192896122673Derf Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00848657076012AED 6250 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Left JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
00848657076029AED 6252 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Right JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
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