FDA.reportPublic FDA data

ERAGON MODULAR

Primary DI
04055207056158
Brand
ERAGON MODULAR
Company
Richard Wolf GmbH
Model
8396225
Catalog number
8396225
Device description
MARYLAND DISSECTOR-INSERT Ø 10MM jaw length 36mm, for SL 447mm, double action, reusable
Published
2022-08-09
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
GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207056158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207056158040552070561584055207056158

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
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
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23
04055207013823NA80611638061.1632016-09-23
04055207013830NA80612538061.2532016-09-23
04055207013854NA80613538061.3532016-09-23
04055207013861NA80613568061.3562016-09-23
04055207013878NA80614538061.4532016-09-23
04055207013885NA80614568061.4562016-09-23
04055207013892NA80614578061.4572016-09-23
04055207013908NA80618538061.8532016-09-23
04055207013922NA80622518062.2512016-09-23
04055207013939NA80623518062.3512016-09-23
04055207013946NA80624518062.4512016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390015TREPSAT FACELIFT DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-23
00196449034512Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
06971503600209comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503600216comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602951comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602968comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602975comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602982comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602999comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603941comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603958comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603965comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603972comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
00841732129337GENERIC Surgical InstrumentsCTL Medical CorporationGDI2025-06-04
00840183523046BR Surgical, LLCBR Surgical, LLCGDI2024-03-06
00850036790013AveliRevelle Aesthetics, Inc.GDI2024-02-26
10840199523402DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533302DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533319 DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533326DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533357DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533364DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533371DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533449DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533456DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533463DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533470DissectorKOROS U.S.A., INC.GDI2024-02-06