FDA.reportPublic FDA data

NA

Primary DI
04055207009857
Brand
NA
Company
Richard Wolf GmbH
Model
838371
Catalog number
8383.71
Device description
HF COAG SUCTION TUBE MONO Ø 5MM WL 315MM 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
KNFCOAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207009857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207009857040552070098574055207009857

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length315Millimeter
Outer Diameter5Millimeter

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;Hydrogen Peroxide;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
DM exempt
false
Premarket exempt
true
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
16932503512227Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-08
16932503512210Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512234Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512241Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512258Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512265Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512272Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512289Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512296Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512302Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512319Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512326Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512333Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512340Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512357Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512364Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512371Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512388Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512395Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512401Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512418Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513187Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513194Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513200Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
14953170466349Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
14953170466356Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
00827002613508SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613512SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613529SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002607842COOKCOOK INCORPORATEDKNS2025-07-22