FDA.report

ERAGON BIPOLAR

Primary DI
04055207033876
Brand
ERAGON BIPOLAR
Company
Richard Wolf GmbH
Model
839300102
Catalog number
839300102
Device description
HANDLE PISTOL SHAPED BIPO without locking mechanism, with bipolar HF-connection, for use with all bipolar ERAGON outer sheath tubes, reusable
Published
2016-09-27
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
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207033876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207033876040552070338764055207033876

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open 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, rigid probe with controls). This is a reusable device.

Sterilization Methods

Method
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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