EM3 Bipolar Adapter, Standard

Primary DI
10815288014161
Brand
EM3 Bipolar Adapter, Standard
Company
ENCISION, INC.
Model
BP9004+
Catalog number
BP9004+
Published
2022-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K122383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122383000EM3 AEM MONITOR AEM CONNECTORSEncision, Inc.2013-01-10GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815288014161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081528801416110815288014161

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical cable adaptorA small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
612250175
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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10815288010248AEM® HandleES8000LES8000L2016-08-31
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