FDA.reportPublic FDA data

ERBE

Primary DI
04050147000629
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
20132-046
Catalog number
20132-046
Device description
Connect. cable for APC applic. APC 2; APC 300; L 2.5 m
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963189000ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIESErbe USA, Inc.1996-11-26GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050147000629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050147000629040501470006294050147000629

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced electrosurgical cableAn noninvasive, flexible, electrical cord with and integrated gas tube intended to be used as part of an argon-enhanced electrosurgical system to enable both electrical connection and argon gas supply from the system generator/gas delivery unit to the handpiece/electrode. It does not include a handpiece. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.5Meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat and direct sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4970717550info@erbe-med.com

Regulatory Flags#

DUNS number
316116623
Device count
1
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
04050147024694Erbe20402-5012026-05-26
04050147023826Erbe20150-12020150-1202026-04-01
04050147023741Erbe10160-0102025-11-03
04050147023161Erbe20180-1002025-10-27
04050147023468Erbe20180-1012025-10-27
04050147023710Erbe20180-1102025-10-14
04050147022959Erbe20150-1112025-10-01
04050147022942Erbe20150-1102025-09-30
04050147023918Erbe20132-32520132-2572025-08-01
04050147023925Erbe20132-32520132-2572025-08-01
04050147024533Erbe20132-25720132-2572025-05-20
04050147024540Erbe20132-25720132-2572025-05-20
04050147017764ERBE20132-25020132-2502019-04-24
04050147017788ERBE20132-25620132-2562019-04-24
04050147018143ERBE20132-25120132-2512019-04-24
04050147018150ERBE20132-25220132-2522019-04-24
04050147018167ERBE20132-25320132-2532019-04-24
04050147018174ERBE20132-25420132-2542019-04-24
04050147024403Erbe20132-25020132-2502025-04-29
04050147024434Erbe20132-25120132-2512025-04-29

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Primary DI, Brand, Company table
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