FDA.reportPublic FDA data

NA

Primary DI
04055207042977
Brand
NA
Company
Richard Wolf GmbH
Model
8734606
Catalog number
8734.606
Device description
FLEX. BIOPSY FORCEPS 4FR WL 600MM double action, TL 730mm, non-dismantling, reusable
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAJCystoscope and accessories, flexible/rigid
FCLFORCEPS, BIOPSY, NON-ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207042977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207042977040552070429774055207042977

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, reusableA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length600Millimeter
Outer Diameter1.33333333333Millimeter

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

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850081334033Zenflow Spring® ScopeZENFLOW, INC.FAJ2026-05-22
00850081334057Zenflow Camera Control UnitZENFLOW, INC.FAJ2026-05-22
06941513200089Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222692Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222708Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222715Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222722Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
00190776418021MillenniumAvalign Technologies, Inc.FCL2026-03-23
06970671381569AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2026-03-23
G3731433010Zinnanti SurgicalZinnanti Surgical Design Group IncFCL2026-03-04
00190776415617MillenniumAvalign Technologies, Inc.FCL2026-01-28
00848657023122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657023139AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657068956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069236AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069243AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069250AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069618AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657074889AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075060AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075084AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075244AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075725AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657076289AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657076692AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078160AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078177AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078184AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078191AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657086936AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23