FDA.reportPublic FDA data

ERAGON MODULAR

Primary DI
04055207056271
Brand
ERAGON MODULAR
Company
Richard Wolf GmbH
Model
8396902
Catalog number
8396902
Device description
SHEATH TUBE Ø 10MM SL 447MM Compatible with all ERAGONmodular 10mm inserts in the respective sheath length, along with ERAGONmodular and ERAGONaxial handles without an HF connection, reusable
Published
2022-11-01
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
FCLFORCEPS, BIOPSY, NON-ELECTRIC
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207056271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207056271040552070562714055207056271

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, reusableA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length447Millimeter
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
08809909421723Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421730Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421747Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421754Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421761Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421778Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421785Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421792Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421808Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
G043201100BEARBear-Ent, LLCGEN2026-04-17
G043201130BEARBear-Ent, LLCGEN2026-04-17
G043201140BEARBear-Ent, LLCGEN2026-04-17
G043201160BEARBear-Ent, LLCGEN2026-04-17
G043201190BEARBear-Ent, LLCGEN2026-04-17
G043201200BEARBear-Ent, LLCGEN2026-04-17
08051887049837THD BIOPSYTHD SPAFCL2026-01-07
08051887049851THD BIOPSYTHD SPAFCL2026-01-07
08051887049875THD BIOPSYTHD SPAFCL2026-01-07
08051887043569THD BIOPSYTHD SPAFCL2025-02-20
08051887045754THD BIOPSYTHD SPAFCL2025-02-20
08051887047413THD BIOPSYTHD SPAFCL2025-02-20
08809909417061Optimos™ Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2025-01-09
08809909417078Optimos™ Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2025-01-09
08809909417085Optimos™ Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2025-01-09
08809909417092Optimos™ Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2025-01-09
08809909417108Optimos™ Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2025-01-09
08809909417115Optimos™ Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2025-01-09
08809909417122Optimos™ Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2025-01-09
08809909417139Optimos™ Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2025-01-09
08809909417146Optimos™ Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2025-01-09