FDA.reportPublic FDA data

PIRANHA

Primary DI
04055207071717
Brand
PIRANHA
Company
Richard Wolf GmbH
Model
49700203
Catalog number
49700203
Device description
MORCELLATOR BLADE LONG Ø 4.8MM WL 385MM for Morcescope, PACK = 3 pcs., for morcellation following laser prostate enucleation, sterile
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FJLResectoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJLResectoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207071717PrimaryGS10
04055207071724Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207071717040552070717174055207071717
04055207071724040552070717244055207071724

GMDN Terms#

Term, Definition table
TermDefinition
Tissue morcellation system handpiece, line-poweredA hand-held component of a tissue morcellation system intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It consists of a high-speed rotating blade in a holder and is connected to a line-powered control unit for the transfer of electrical energy or rotational power (via an electrical or remote drive cable); a handpiece obturator, and a disposable remote drive cable may be included. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length385Millimeter
Outer Diameter4.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04055207013823NA80611638061.1632016-09-23
04055207013830NA80612538061.2532016-09-23
04055207013854NA80613538061.3532016-09-23
04055207013861NA80613568061.3562016-09-23
04055207013878NA80614538061.4532016-09-23
04055207013885NA80614568061.4562016-09-23
04055207013892NA80614578061.4572016-09-23
04055207013908NA80618538061.8532016-09-23
04055207013922NA80622518062.2512016-09-23
04055207013939NA80623518062.3512016-09-23
04055207013946NA80624518062.4512016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207048788NARichard Wolf GmbHFJL2026-05-13
04055207071731PIRANHARichard Wolf GmbHFJL2025-11-17
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
00860011104438VeloxionAulea Medical Inc.FJL2025-01-03
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
04048438005408n.a.Karl Storz GmbH & Co. KGFJL2024-10-04
04055207007822NARichard Wolf GmbHFJL2024-08-19
04055207008393NARichard Wolf GmbHFJL2024-08-19
04055207058985NARichard Wolf GmbHFJL2024-08-19
04055207069936NARichard Wolf GmbHFJL2024-08-19
04055207011911NARichard Wolf GmbHFJL2024-08-19
04055207038673NARichard Wolf GmbHFJL2024-04-01
04055207069783NARichard Wolf GmbHFJL2024-04-01
04055207057322SHARKRichard Wolf GmbHFJL2024-03-29
04055207055106PANOVIEWRichard Wolf GmbHFJL2023-08-03
04055207055113PANOVIEWRichard Wolf GmbHFJL2023-08-03
14042761085493OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085530OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085547OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085554OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085561OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085578OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27