FDA.report

NA

Primary DI
04055207065495
Brand
NA
Company
Richard Wolf GmbH
Model
86754265
Catalog number
86754265
Device description
OUTER SHEATH RESECTOSCOPE 26FR
Published
2020-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FJLResectoscope

Product Code Classifications

CodeDeviceSpecialtyClass
FJLResectoscopeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207065495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207065495040552070654954055207065495

GMDN Terms

TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter8.66666666666Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04055207071724PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071748PIRANHARichard Wolf GmbHFJL2025-11-17
00848657077507AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2025-08-25
04048551411704NAKarl Storz GmbH & Co. KGFJL2025-03-27
00860011104407VeloxionAulea Medical Inc.FJL2025-01-03
00860011104414VeloxionAulea Medical Inc.FJL2025-01-03
00860011104421VeloxionAulea Medical Inc.FJL2025-01-03
00860011104483VeloxionAulea Medical Inc.FJL2025-01-03
00860011104445VeloxionAulea Medical Inc.FJL2025-01-03
00860011104452VeloxionAulea Medical Inc.FJL2025-01-03
04055207069936NARichard Wolf GmbHFJL2024-08-19
04055207069783NARichard Wolf GmbHFJL2024-04-01
04055207057322SHARKRichard Wolf GmbHFJL2024-03-29
04055207055106PANOVIEWRichard Wolf GmbHFJL2023-08-03
04055207055113PANOVIEWRichard Wolf GmbHFJL2023-08-03
04055207065464NARichard Wolf GmbHFJL2020-02-24
04055207065471NARichard Wolf GmbHFJL2020-02-24
04055207065488NARichard Wolf GmbHFJL2020-02-24
00848657068536AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2019-06-13
00848657070423AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2019-06-13
00848657085519AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2019-06-13
00848657087056AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2019-06-13
04055207028063E-LINERichard Wolf GmbHFJL2018-06-11
04059082031873UreterorenoscopeSOPRO-COMEG GmbHFJL2018-03-20
04059082031880UreterorenoscopeSOPRO-COMEG GmbHFJL2018-03-20
04059082031897UreterorenoscopeSOPRO-COMEG GmbHFJL2018-03-20
04059082031903UreterorenoscopeSOPRO-COMEG GmbHFJL2018-03-20
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04059082031927UreterorenoscopeSOPRO-COMEG GmbHFJL2018-03-20
04059082031934UreterorenoscopeSOPRO-COMEG GmbHFJL2018-03-20