FDA.reportPublic FDA data

Bipolar connecting cable

Primary DI
04250676736864
Brand
Bipolar connecting cable
Company
Spiggle & Theis Medizintechnik GmbH
Model
80-318-50
Device description
Bipolar connecting cable, compatible with Erbe/Storz/Wolf, unit-side, 5 m
Published
2020-03-05
Public version status
New
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
K981919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981919000BISSINGER CABLES, CAT. NO. 801000XXGuenter Bissinger Medizintechnik GmbH1998-08-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676736864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676736864042506767368644250676736864

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Meter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+492206908153p.stockmann@spiggle-theis.com

Regulatory Flags#

DUNS number
332893028
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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