FDA.report

ERBE

Primary DI
04050147000902
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
20132-113
Catalog number
20132-113
Device description
APC-applicator 300 A, rigid, OD: 2.3 mm, L: 300 mm
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050147000902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050147000902040501470009024050147000902

GMDN Terms

TermDefinition
Argon-enhanced open-surgery electrosurgical electrodeA rigid, invasive, distal component of an argon-enhanced electrosurgical system intended to be connected to a handpiece (not included) to deliver electrosurgical current within a stream of argon (Ar) gas directly to tissues for cutting/coagulation during open surgery. It is typically designed as a coaxial arrangement of a monopolar electrode within an Ar gas delivery sleeve; it requires a patient contact return electrode to complete the circuit. This is a reusable device.

Device Sizes

TypeValueUnit
Length300Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat and direct sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+4970717550info@erbe-med.com

Regulatory Flags

DUNS number
316116623
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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