FDA.report

ERAGON MODULAR

Primary DI
04055207016770
Brand
ERAGON MODULAR
Company
Richard Wolf GmbH
Model
8395225
Catalog number
8395.225
Device description
MARYLAND DISSECTOR-INSERT Ø 10MM jaw length 36mm, for SL 327mm, double action, reusable
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery
GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207016770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207016770040552070167704055207016770

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter10Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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