FDA.reportPublic FDA data

HYSAFE

Primary DI
04055207028926
Brand
HYSAFE
Company
Richard Wolf GmbH
Model
89596218
Catalog number
8959.6218
Device description
GRASP. FORCEPS INSERT 5FR mouse tooth, double action, WL 425 mm, with irrigation connection, take-apart, reusable
Published
2023-01-03
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
OCZEndoscopic grasping/cutting instrument, non-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207028926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207028926040552070289264055207028926

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.66666666666Millimeter
Outer Diameter1.66666667Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

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
04953170466137Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
04953170466144Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
04953170466151Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
04953170466168Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466134Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466141Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466158Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466165Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
00816207021386EndoTBasketENDO-THERAPEUTICS, INC.OCZ2025-02-26
10816207021383EndoTBasketENDO-THERAPEUTICS, INC.OCZ2025-02-26
04260206311706stentfix OTSC System SetOvesco Endoscopy Usa, Inc.OCZ2024-09-13
00860001219821ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219845ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219852ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219838ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
04055207027820HYSAFERichard Wolf GmbHOCZ2023-01-10
04055207028940HYSAFERichard Wolf GmbHOCZ2023-01-10
04055207028957HYSAFERichard Wolf GmbHOCZ2023-01-10
04055207041130HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028902HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027783HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027790HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027806HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027813HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028858HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028865HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028872HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028889HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028933HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027776HYSAFERichard Wolf GmbHOCZ2023-01-03