FDA.reportPublic FDA data

Hermann Medizintechnik GmbH

Primary DI
04059453007674
Brand
Hermann Medizintechnik GmbH
Company
Hermann Medizintechnik GmbH
Model
H43-533-990
Device description
KELLY Grasping Forceps, Ø5mm, WL 330mm, double action jaw, shaft insulated, plastic handle/ ratchet deactivatable, HF-connection, detachable
Published
2021-07-21
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051610000HANS HERMANN LAPAROSCOPES AND ACCESSORIESHans Hermann GmbH2005-07-29GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059453007674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059453007674040594530076744059453007674

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49746299670info@hermann-medizintechnik.de

Regulatory Flags#

DUNS number
324868165
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059453116635Hermann Medizintechnik GmbHH142-810102026-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18