FDA.reportPublic FDA data

Hermann Medizintechnik GmbH

Primary DI
04059453023391
Brand
Hermann Medizintechnik GmbH
Company
Hermann Medizintechnik GmbH
Model
H19-133-985
Device description
Needle holder, 60° angled, Ø10mm, WL 330mm, double action jaw, shaft insulated, axial handle/ ratchet, detachable
Published
2021-04-28
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
04059453023391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059453023391040594530233914059453023391

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

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
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
04059453146922Hermann Medizintechnik GmbHH174-379102026-03-09
04059453049223Hermann Medizintechnik GmbHH-054 2026-03-02
04059453062727Hermann Medizintechnik GmbHH108-233232026-02-24
04059453054722Hermann Medizintechnik GmbHH50-005-0132026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08