FDA.reportPublic FDA data

Guenter Bissinger Medizintechnik GmbH

Primary DI
04250418747868
Brand
Guenter Bissinger Medizintechnik GmbH
Company
Günter Bissinger Medizintechnik GmbH
Model
84630400
Catalog number
84630400
Device description
Needle Holder TC straight Ø 3mm 330 mmstraight axial handle, non detachable
Published
2025-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04250418747868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250418747868042504187478684250418747868

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
+497641914330info@bissinger.com

Regulatory Flags#

DUNS number
326515533
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250418748346Guenter Bissinger Medizintechnik GmbH82460326824603262026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbH82460349824603492026-07-21
04250418753395Guenter Bissinger Medizintechnik GmbH84919320849193202025-03-27
04250418753401Guenter Bissinger Medizintechnik GmbH84919321849193212025-03-27
04250418753418Guenter Bissinger Medizintechnik GmbH84921320849213202025-03-27
04250418753425Guenter Bissinger Medizintechnik GmbH84921321849213212025-03-27
04250418753432Guenter Bissinger Medizintechnik GmbH84923320849233202025-03-27
04250418753449Guenter Bissinger Medizintechnik GmbH84923321849233212025-03-27
04250418753296Guenter Bissinger Medizintechnik GmbH84923301849233012025-01-02
04250418753302Guenter Bissinger Medizintechnik GmbH84923310849233102025-01-02
04250418753319Guenter Bissinger Medizintechnik GmbH84923311849233112025-01-02
04250418753326Guenter Bissinger Medizintechnik GmbH84923330849233302025-01-02
04250418753333Guenter Bissinger Medizintechnik GmbH84923340849233402025-01-02
04250418753258Guenter Bissinger Medizintechnik GmbH84921311849213112024-12-18
04250418753265Guenter Bissinger Medizintechnik GmbH84921330849213302024-12-18
04250418753272Guenter Bissinger Medizintechnik GmbH84921340849213402024-12-18
04250418753289Guenter Bissinger Medizintechnik GmbH84923300849233002024-12-18
04250418753166Guenter Bissinger Medizintechnik GmbH84919300849193002024-12-17
04250418753173Guenter Bissinger Medizintechnik GmbH84919301849193012024-12-17
04250418753180Guenter Bissinger Medizintechnik GmbH84919310849193102024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995279622V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286248V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286286V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320164V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320263V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320317V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320324V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320331V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320348V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00840319759424Hayden MedicalHayden Medical, Inc.FHQ2026-09-04
00190776419684MillenniumAvalign Technologies, Inc.FHQ2026-08-25
00850083997007Suture SheildSUTURE SHIELD, INC.FHQ2026-08-03
B382SD45267180Surgical DirectSurgical Direct, Inc.FHQ2026-08-03
B382SD90557818E0Surgical DirectSurgical Direct, Inc.FHQ2026-07-29
00810143905076SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905083SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905106SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143907193SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908671SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908701SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909081SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909753SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909760SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931517SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931678SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934709SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934716SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934723SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934921SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934938SURGIPROSSurgipros, LLCFHQ2026-07-28