FDA.reportPublic FDA data

NA

Primary DI
04055207043110
Brand
NA
Company
Richard Wolf GmbH
Model
8766951
Catalog number
8766.951
Device description
ARTICULAR ARM LEYLA reusable
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04055207043110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207043110040552070431104055207043110

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

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29
04055207038529RIWO880288.022026-05-29
04055207038536RIWO880488.042026-05-29
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23

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