FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653172443
Brand
AESCULAP
Company
Aesculap AG
Model
GK366R
Catalog number
GK366R
Device description
MINOP MONOPOLAR HOOK ELECTRODE 180DG
Published
2016-09-23
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
GWGENDOSCOPE, NEUROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWGEndoscope, NeurologicalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653172443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653172443040386531724434038653172443

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800112400161cCeLLVPIX Medical, Inc.GWG2026-05-11
08800112400178cCeLLVPIX Medical, Inc.GWG2026-05-11
00860000321389Neuroblade SystemClearmind Biomedical Inc.GWG2026-05-11
00810004821064Clarus Digital ChannelScope Endoscope, 21.6cm, 3mm WCCLARUS MEDICAL, LLCGWG2026-04-21
00810004821071Clarus Digital ChannelScope Endoscope, 13.0cm, 3mm WCCLARUS MEDICAL, LLCGWG2026-04-21
00810004821118Digital MurphyScope EndoscopeCLARUS MEDICAL, LLCGWG2026-04-21
00840067103029ZenithCADWELL INDUSTRIES, INC.GWG2025-12-31
04048551418123n.a.Karl Storz GmbH & Co. KGGWG2025-08-11
04048438000175NAKarl Storz GmbH & Co. KGGWG2025-03-27
00810004820401Clarus Digital ChannelScope Endoscope, 21.6cm, 3.5mm ODCLARUS MEDICAL, LLCGWG2024-12-23
00810004820418Clarus Digital ChannelScope Endoscope, 21.6cmCLARUS MEDICAL, LLCGWG2024-12-23
04048551425695n.a.Karl Storz GmbH & Co. KGGWG2024-12-20
04048551436271n.a.Karl Storz GmbH & Co. KGGWG2024-11-28
10884521844681VS3 IridiumVISIONSENSE LTD.GWG2024-11-11
04048551436240n.a.Karl Storz GmbH & Co. KGGWG2024-10-18
04055207008317RIWORichard Wolf GmbHGWG2024-08-19
04055207069981RIWORichard Wolf GmbHGWG2024-08-19
10810004821016Clarus Digital Control ModuleCLARUS MEDICAL, LLCGWG2024-02-19
076133276089151788STRYKER CORPORATIONGWG2023-12-11
00850002332285Aurora® Surgiscope®Integra Lifesciences CorporationGWG2023-11-09
00850002332292Aurora® Surgiscope®Integra Lifesciences CorporationGWG2023-11-09
10884521834644VS3-IRVISIONSENSE LTD.GWG2022-05-09
00860000321310Axonpen SystemClearmind Biomedical Inc.GWG2022-02-18
00860000321334ClearPathClearmind Biomedical Inc.GWG2022-02-18
00850002332247AURORA® Surgiscope®Integra Lifesciences CorporationGWG2021-05-18
00850002332254AURORA® Surgiscope®Integra Lifesciences CorporationGWG2021-05-18
10813040013704VS3-IRVISIONSENSE LTD.GWG2020-06-11
10813040013711VS3-IRVISIONSENSE LTD.GWG2020-06-11
10813040013728VS3-IRVISIONSENSE LTD.GWG2020-06-11
10813040013117VS3-IRVISIONSENSE LTD.GWG2020-04-07