FDA.reportPublic FDA data

HYSAFE

Primary DI
04055207028889
Brand
HYSAFE
Company
Richard Wolf GmbH
Model
89526508
Catalog number
8952.6508
Device description
GRASP. FORCEPS INSERT 5FR pike-mouth short, double action, WL 550 mm, 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
04055207028889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207028889040552070288894055207028889

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
04055207028926HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028933HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027776HYSAFERichard Wolf GmbHOCZ2023-01-03