BiCap Superconductor

Primary DI
30653405046800
Brand
BiCap Superconductor
Company
Conmed Corporation
Model
BP-10300A
Catalog number
BP-10300A
Device description
BiCap Superconductor Bipolar Probe, Hemostasis Probe, 10Fr/300 cm
Published
2016-09-24
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
FEHELECTRODE, FLEXIBLE SUCTION COAGULATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEHElectrode, Flexible Suction CoagulatorGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K803214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K803214000ACMI BIPOLAR HEMOSTATIC ELECTRODEAmerican Cystocope Makers, Inc.1981-01-15FEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30653405046800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065340504680030653405046800

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length300Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Handling Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Humidity5 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3708070260CAMERON-MILLERCAMERON-MILLER INCFEH2017-02-11
30653405046992BiCap SuperconductorConmed CorporationFEH2016-09-24
30653405047005BiCap SuperconductorConmed CorporationFEH2016-09-24
30653405047012BiCap SuperconductorConmed CorporationFEH2016-09-24
30653405047029BiCap SuperconductorConmed CorporationFEH2016-09-24