FDA.reportPublic FDA data

ASSISTO® Arm-System

Primary DI
14049679077787
Brand
ASSISTO® Arm-System
Company
GEOMED Medizin-Technik GmbH & Co. KG
Model
CI 404-01-01
Device description
ASSISTO FOR K SUPPORT
Published
2018-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
14049679077787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1404967907778714049679077787

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316151174
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14049679077428Assisto® Arm-SystemCE 401-40-012021-07-19
14049679046165HERCULES® Wire CutterOL 603-18-012020-11-17
14049679046202HERCULES® Wire CutterOL 605-23-012020-11-17
14049679046288HERCULES® Wire CutterOL 620-28-012020-11-17
14049679095613HERCULES® Wire CutterOL 610-23-012020-11-17
14049679077374Assisto® Arm-SystemCE 403-40-012020-01-31
14049679077831Assisto® Arm-SystemCI 422-00-092019-04-29
14049679076681ASSISTO® Arm-SystemCA 235-30-01CA 235-30-012017-02-23
14049679076735ASSISTO® Arm-SystemCA 301-20-01CA 301-20-012016-12-20
14049679076803ASSISTO® Arm-SystemCA 305-22-01CA 305-22-012016-12-19
14049679078425Assisto® Arm-SystemCI 415-02-012019-03-01
14049679079583ASSISTO® Arm-SystemCI 310-50-012019-03-01
14049679092957ASSISTO® Arm-SystemCA 450-40-012018-05-22

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