ERBE

Primary DI
04050147020108
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
20150-215
Catalog number
20150-215
Device description
HybridAPC probe OD 2.3mm; L 1.9m
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K143306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143306000ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.2015-10-27GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050147020108PackageGS15In Commercial Distribution
04050147020092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050147020108040501470201084050147020108
04050147020092040501470200924050147020092

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced endoscopic electrosurgical submucosal lift/resection instrumentA flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) electrosurgical current within a stream of argon (Ar) gas (in a monopolar configuration) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent ablation of the diseased area by argon plasma coagulation. It is a long, thin electrode/luminal needle intended to be connected to the appropriate parent devices (i.e., argon-enhanced electrosurgical system generator/gas delivery unit, and fluid pump); it does not include any controls. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.9Meter

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

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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