FDA.reportPublic FDA data

NA

Primary DI
04055207042847
Brand
NA
Company
Richard Wolf GmbH
Model
8642631
Catalog number
8642.631
Device description
RIGID BIOPSY FORCEPS 5FR WL 355MM single action, TL 470mm, non-dismantling, reusable
Published
2016-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCLFORCEPS, BIOPSY, NON-ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207042847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207042847040552070428474055207042847

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy punch, reusableA manual surgical instrument designed to obtain a tissue or bone sample typically for histopathological analysis. The instrument may be ring-handled, pistol grip, or shaft-like in design. Ring-handled or pistol grip designs feature extended shafts which terminate in a punch-like or mechanical jaw mechanism at the distal tip. The shaft-like instrument is a hollow tube, sharpened on one end, and is usually used with a trocar. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length355Millimeter
Outer Diameter1.66666666666Millimeter
Outer Diameter1.66666667Millimeter

Sterilization Methods#

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

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
04055207000649NA799000179900012021-04-05
04055207000656NA799000279900022021-04-05
04055207058862NA799000379900032021-04-05
04055207070055NA10300103.002024-06-03
04055207058886NA82295822952022-08-09
04055207038758FUSION DESIGN8095098095092022-03-08
04055207055199FUSION DESIGN8070028070022022-03-08
04055207065730VERTEBRIS1520826415208.2642022-11-01
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27
04055207055540ERAGON BIPOLAR83930037839300372016-09-27
04055207066805NA880888.082026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423681MillenniumAvalign Technologies, Inc.FCL2026-08-07
B382SD13024290Surgical DirectSurgical Direct, Inc.FCL2026-07-14
06959664900000NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900215NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900222NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910788NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910801NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910832NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910863NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911365NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911372NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911389NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911396NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944035NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944042NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944059NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944066NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944073NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944080NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944097NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944103NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944110NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944127NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944134NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944141NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944165NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944172NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06975339628512Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628529Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628536Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03