FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963186531
Brand
AESCULAP
Company
Aesculap AG
Model
FH604SU
Catalog number
FH604SU
Device description
MINOP DISPOSABLE INTRODUCER 19FR
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
04046963186531PrimaryGS10
04046963178864Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963186531040469631865314046963186531
04046963178864040469631788644046963178864

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral trocar bladeA sterile, hand-held, manual surgical instrument with a sharp, needle-like point intended to be used in conjunction with an intracerebral catheter (e.g., ventricular catheter) to puncture tissue and create a channel to access the brain (e.g., cerebral ventricles, cystic tumours) typically for cerebrospinal fluid (CSF) drainage or infusion of materials (e.g., chemotherapeutic agents). It is inserted within the lumen of the intracerebral catheter prior to catheter insertion; the catheter is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315018218
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04048551436271n.a.Karl Storz GmbH & Co. KGGWG2024-11-28
04055207069981RIWORichard Wolf GmbHGWG2024-08-19
00810004820012Clarus Digital ChannelScope Endoscope, 13.0cmCLARUS MEDICAL, LLCGWG2024-02-19
00810004820357Clarus Digital NeuroPEN Endoscope, 15.5cmCLARUS MEDICAL, LLCGWG2024-02-19
00810004820395Clarus Digital ChannelScope Endoscope, 11.0cmCLARUS MEDICAL, LLCGWG2024-02-19
00810004820494Clarus Digital NeuroPEN Endoscope, 19.0cmCLARUS MEDICAL, LLCGWG2024-02-19
00810004821026Clarus Digital ClarusScope EndoscopeCLARUS MEDICAL, LLCGWG2024-02-19
00810004821019Clarus Digital Control ModuleCLARUS MEDICAL, LLCGWG2024-02-19
00850002332278Aurora® Surgiscope®Integra Lifesciences CorporationGWG2023-11-09
10813040013704VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR)VISIONSENSE LTD.GWG2020-06-11
10813040013728VS3 Iridium - Laser Light Source, 785nm (LLS)VISIONSENSE LTD.GWG2020-06-11
10813040013032Power Cord for VS3 Cart - ItalyVISIONSENSE LTD.GWG2019-11-25
10813040013070Power Cord for VS3 Cart - USVISIONSENSE LTD.GWG2019-11-25
04048551105221n.a.Karl Storz GmbH & Co. KGGWG2017-10-20
04048551396001TIPCAMKarl Storz GmbH & Co. KGGWG2017-05-19
04048551396018TIPCAMKarl Storz GmbH & Co. KGGWG2017-05-19
04048551007624n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007631n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007648n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007655n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007778n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007785n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007792n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007815CLICKLINEKarl Storz GmbH & Co. KGGWG2016-09-23
04048551007907n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007914n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007921n.a.Karl Storz GmbH & Co. KGGWG2016-09-23