FDA.reportPublic FDA data

SCANLAN® Advantage™ Badie™ Suction Bipolar Forceps

Primary DI
00846159023077
Brand
SCANLAN® Advantage™ Badie™ Suction Bipolar Forceps
Company
SCANLAN INTERNATIONAL INC
Model
4004-410
Catalog number
4004-410
Device description
SCANLAN® Advantage™ Bipolar Forceps
Published
2018-05-21
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159023077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159023077008461590230778461590230770846159023077

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, reusableA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during argon-enhanced electrosurgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159040678SCANLAN® Minimally-Invasive InstrumentationQ29142-9Q29142-92026-07-17
00846159040685SCANLAN Minimally-Invasive InstrumentationQ29150-9Q29150-92026-07-17
00846159040692SCANLAN Minimally-Invasive InstrumentationQ29163-9Q29163-92026-07-17
00846159040708SCANLAN®9009-941P9009-941P2026-07-17
00846159036152SCANLAN® Bulldog Clamp3795-453795-452026-06-23
00846159036404SCANLAN® Bulldog Clamp3795-553795-552026-06-09
00846159040524SCANLAN® Retractor8008-568008-562026-06-04
00846159040531SCANLAN® Retractor8008-598008-592026-06-04
00846159040548SCANLAN® Retractor8008-608008-602026-06-04
00846159040555SCANLAN® Retractor8888-058888-052026-06-04
00846159040562SCANLAN® Retractor8888-588888-582026-06-04
00846159040579SCANLAN® Retractor8989-188989-182026-06-04
00846159040586SCANLAN® RetractorQ195Q1952026-06-04
00846159040593SCANLAN® RetractorQ219Q2192026-06-04
00846159040609SCANLAN® RetractorQ222Q2222026-06-04
00846159040616SCANLAN® RetractorQ28124-38-2NQ28124-38-2N2026-06-04
00846159040623SCANLAN® RetractorQ28124-38-3NQ28124-38-3N2026-06-04
00846159040388SCANLAN® Retractor8008-1828008-1822026-06-03
00846159040395SCANLAN® Retractor8008-2008008-2002026-06-03
00846159040401SCANLAN® Retractor8008-2028008-2022026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405922MillenniumAvalign Technologies, Inc.GEI2026-07-26
00190776405939MillenniumAvalign Technologies, Inc.GEI2026-07-26
00841019123959KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123966KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123973KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123980KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123997KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00190776405809MillenniumAvalign Technologies, Inc.GEI2026-07-24
00841019123867KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-24
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17