FDA.reportPublic FDA data

Hermann Medizintechnik GmbH

Primary DI
04059453011428
Brand
Hermann Medizintechnik GmbH
Company
Hermann Medizintechnik GmbH
Model
H35-000-000
Catalog number
H35-000-000
Device description
Compact metal handle with ratchet, non-insulated
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059453011428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059453011428040594530114284059453011428

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgery handleA hand-held manual surgical instrument intended to be used during laparoscopy to perform a variety of surgical manipulations with various attachable tips/ends; it does not facilitate irrigation or aspiration (suction). It is typically made of metal and/or synthetic material with a straight handle grip. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+490746399670info@hermann-medizintechnik.de

Regulatory Flags#

DUNS number
324868165
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059453095022Hermann Medizintechnik GmbHH132-635092026-07-27
04059453084217Hermann Medizintechnik GmbHH124-144132026-07-16
04059453127471Hermann Medizintechnik GmbHH146-455062026-07-16
04059453127891Hermann Medizintechnik GmbHH146-471072026-07-16
04059453133809Hermann Medizintechnik GmbHH152-272222026-07-16
04059453072832Hermann Medizintechnik GmbHH112-447212026-07-13
04059453162618Hermann Medizintechnik GmbHH-585.2026-07-13
04059453161574Hermann Medizintechnik GmbHH-5062026-06-03
04059453162762Hermann Medizintechnik GmbHH-594HM2026-05-29
04059453163318Hermann Medizintechnik GmbHH65-05402026-05-29
04059453140418Hermann Medizintechnik GmbHH168-430002026-05-21
04059453078087Hermann Medizintechnik GmbHH118-280082026-05-12
04059453078810Hermann Medizintechnik GmbHH118-348222026-05-12
04059453122254Hermann Medizintechnik GmbHH144-280082026-05-12
04059453062581Hermann Medizintechnik GmbHH108-218182026-04-27
04059453076052Hermann Medizintechnik GmbHH118-127112026-04-27
04059453158444Hermann Medizintechnik GmbHH-329HM2026-04-07
04059453158611Hermann Medizintechnik GmbHH-333HM2026-04-07
04059453163783Hermann Medizintechnik GmbHH-661HM 2026-03-31
04059453056535Hermann Medizintechnik GmbHH50-050-000 2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28