FDA.reportPublic FDA data

Hermann Medizintechnik GmbH

Primary DI
04059453021748
Brand
Hermann Medizintechnik GmbH
Company
Hermann Medizintechnik GmbH
Model
H80-000-19
Device description
Applicator f. Endo-LigatureReducer Sleeve ø5 to ø 4mm, WL 175mm
Published
2017-06-22
Public version status
Update
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
04059453021748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059453021748040594530217484059453021748

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula seal reducerA small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49746299670info@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
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
04059453049339Hermann Medizintechnik GmbHH1002-12HM2026-03-10

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Primary DI, Brand, Company table
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B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
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B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
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00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
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B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
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00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
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