FDA.reportPublic FDA data

GREENLIGHT

Primary DI
04055207018231
Brand
GREENLIGHT
Company
Richard Wolf GmbH
Model
8632911
Catalog number
8632.911
Device description
LASER WORKING INSERT 12/30 color code green, round, with pivot angle limitation, distal sheath end slanted, compatible with sheaths 8632027, 8655345, and telescopes Ø 4mm, 0°-30°, bayonet-cap, reusable
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBOCYSTOURETHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBOCystourethroscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207018231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207018231040552070182314055207018231

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope working guideAn endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

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
04048438000175NAKarl Storz GmbH & Co. KGFBO2025-03-27
04048551431382n.a.Karl Storz GmbH & Co. KGFBO2024-11-28
04953170438158Biopsy ValveOLYMPUS MEDICAL SYSTEMS CORP.FBO2023-04-22
04953170451980Luer-Split MAJ-2092OLYMPUS MEDICAL SYSTEMS CORP.FBO2022-08-05
04055207066218E-LINERichard Wolf GmbHFBO2020-02-21
04055207066225E-LINERichard Wolf GmbHFBO2020-02-21
04055207066195E-LINERichard Wolf GmbHFBO2020-02-21
04055207066201E-LINERichard Wolf GmbHFBO2020-02-21
04048551327746n.a.Karl Storz GmbH & Co. KGFBO2019-02-23
04048551390139n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390160n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390184n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390238n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390146n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390177n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
00821925038547Gyrus ACMIGyrus ACMI, LLCFBO2016-10-18
00821925007772Adapter PK Working Element Gyrus® PK™ SuperPulse™ SystemGyrus Acmi, Inc.FBO2016-10-18
00821925001374Gyrus ACMIGyrus ACMI, LLCFBO2016-10-13
00821925001916USA EliteGyrus ACMI, LLCFBO2016-10-13
00821925001947Elite BipolarGyrus ACMI, LLCFBO2016-10-13
00821925011229Elite IglesiasGyrus ACMI, LLCFBO2016-10-13
00821925008229USA Elite Gyrus ACMI, LLCFBO2016-10-05
00821925008243EliteGyrus ACMI, LLCFBO2016-10-05
00821925027275Gyrus ACMIGyrus ACMI, LLCFBO2016-10-05
04055207018385NARichard Wolf GmbHFBO2016-09-29
04055207018392NARichard Wolf GmbHFBO2016-09-29
04055207018491NARichard Wolf GmbHFBO2016-09-29
04055207018194MOXYRichard Wolf GmbHFBO2016-09-27
04055207018255GREENLIGHTRichard Wolf GmbHFBO2016-09-27
04055207018286E-LINERichard Wolf GmbHFBO2016-09-27