FDA.reportPublic FDA data

ERBE

Primary DI
04050147000698
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
20132-059
Catalog number
20132-059
Device description
APC membrane filter, 0.2 µm
Published
2017-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K024047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024047000ERBE VIO APC WITH ACCESSORIESErbe USA, Inc.2003-01-08GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050147017313PackageGS150In Commercial Distribution
04050147000698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050147017313040501470173134050147017313
04050147000698040501470006984050147000698

GMDN Terms#

Term, Definition table
TermDefinition
Inert gas-enhanced electrosurgical system filterA device intended to prevent fluids and bacterial contaminants from entering an inert gas-enhanced electrosurgical system generator during surgical procedures. It is a meshed piece placed between the generator and the connected handpiece/electrode. This is a single-use device.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
316116623
Device count
1
Lot or batch
true
Expiration 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
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
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21