FDA.reportPublic FDA data

ERBE

Primary DI
04050147000933
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
20132-116
Catalog number
20132-116
Device description
APC-applicator 500 A OD: 2.3 mm, L: 500 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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050147000933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050147000933040501470009334050147000933

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length500Millimeter

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050147024694Erbe20402-5012026-05-26
04050147023925Erbe20132-32520132-2572025-08-01
04050147024540Erbe20132-25720132-2572025-05-20
04050147024410Erbe20132-25020132-2502025-04-29
04050147024441Erbe20132-25120132-2512025-04-29
04050147024465Erbe20132-25220132-2522025-04-29
04050147024489Erbe20132-25320132-2532025-04-29
04050147024502Erbe20132-25420132-2542025-04-29
04050147024526Erbe20132-25520132-2552025-04-29
04050147024564Erbe20132-25620132-2562025-04-29
04050147023529Erbe20160-01120160-0112025-04-07
04050147023581Erbe20132-32120132-3212025-02-11
04050147023666Erbe20132-32320132-3232025-02-11
04050147023642Erbe20132-32420132-3242025-02-11
04050147022751Erbe20220-10020220-1002025-01-21
04050147022768Erbe20220-11020220-1102025-01-21
04050147022775Erbe20220-00020220-0002025-01-21
04050147022782Erbe20220-01020220-0102025-01-21
04050147023543Erbe20220-00120220-0012025-01-21
04050147023550Erbe20220-01120220-0112025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850067560316LaproSacSurgical Principals, IncGEI2026-05-22
ESUM3644100SutterSutter Medizintechnik GmbHGEI2026-05-22
00845854035590CONCEPTConmed CorporationGEI2026-03-24
00190776417932MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776417956MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418076MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418281MillenniumAvalign Technologies, Inc.GEI2026-03-23
00653405013924CONMEDConmed CorporationGEI2026-03-23
00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
00198506089749ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108166DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108180DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108197DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108203DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108289DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108272DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108296DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108302DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108319DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108326DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108395POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108401POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108425POTENZAJeisys Medical Inc.GEI2026-03-16
00198506089565ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-13
10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
10884450587802STAR™Merit Medical Systems, Inc.GEI2026-03-11
08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09