FDA.reportPublic FDA data

SHARK

Primary DI
04055207055304
Brand
SHARK
Company
Richard Wolf GmbH
Model
8654998
Catalog number
8654998
Device description
CURETTE 22-24FR for continuous irrigation laser resectoscope, for prostate chips, reusable
Published
2016-09-23
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
FDCRESECTOSCOPE, WORKING ELEMENT
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDCResectoscope, Working ElementGastroenterology, Urology2
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207055304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207055304040552070553044055207055304

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

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

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
Premarket exempt
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10653160374862CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-05-18
08806395489848PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
08806395489855PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
08806395489862PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
10653160357506CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2023-01-13
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07898506848942QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506849260QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506849314QuinelatoSchobell Industrial LtdaHTF2023-01-09
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07898506853809QuinelatoSchobell Industrial LtdaHTF2023-01-09
EZPF41891040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-16
EZPF4185501ZS0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-08
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10653160278795CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01
10653160279846CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01