FDA.reportPublic FDA data

ERBE

Primary DI
04050147015692
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
10135-000
Catalog number
10135-000
Device description
Erbe APC 3 Argon Plasma Coagulation Unit
Published
2020-01-22
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
K191234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191234000APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening setsErbe Elektromedizin GmbH2019-12-20GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050147015692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050147015692040501470156924050147015692

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced electrosurgical system gas delivery unitA device designed to deliver argon (Ar) gas from an Ar gas source to an argon-enhanced electrosurgical system. It is typically incorporated into a trolley (cart) and is connected to the electrosurgical diathermy generator, enabling a single control for the system. The argon gas is delivered through an appropriate handpiece and active electrode (not included) to minimize tissue charring and enhance coagulation at and around the site of operation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius70 Degrees Celsius
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Keep away from heat and direct sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
316116623
Device count
1
Serial number
true
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433062MillenniumAvalign Technologies, Inc.GEI2026-10-01
10884521740150LigaSureCovidien LPGEI2026-10-01
00190776432980MillenniumAvalign Technologies, Inc.GEI2026-09-30
B382SD070823101310Surgical DirectSurgical Direct, Inc.GEI2026-09-30
10884450452353STAR™Merit Medical Systems, Inc.GEI2026-09-29
00190776432645MillenniumAvalign Technologies, Inc.GEI2026-09-28
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21