FDA.reportPublic FDA data

Smith and Nephew

Primary DI
B504AEACH4040010
Brand
Smith and Nephew
Company
Provision
Model
ACH4040-01
Published
2020-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504AEACH4040010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessedA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open 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, rigid probe with controls). This is a previously used single-use device that has been processed for an additional single-use patient application.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature7 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
541-422-8880mark@provisiondrs.com

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504OM4515700130DePuy Mitek4515700132026-03-19
B504OM50715940Conmed Linvatec5071-5942026-03-19
B504OMDC119090180Conmed LinvatecDC119-090-182026-03-19
B504OMPDS2NL300NakanishiPDS-2NL-302026-02-09
B504OM13090119XG10Zimmer13090119XG12025-11-25
B504OM19100119XG10Zimmer19100119XG12025-11-25
B504OM20090119XC10Zimmer20090119XC12025-11-25
B504OM20100119XC10Zimmer20100119XC12025-11-25
B504OM20100119XCW0Zimmer20100119XCW2025-11-25
B504OM21090119XGW0Zimmer21090119XGW2025-11-25
B504OM17090127YGS0Zimmer17090127YGS2025-09-03
B504OM0145080Smith and Nephew0145082025-06-19
B504OM254400111D0DePuy Mitek2544-00-111-D2025-06-10
B504OM254400111P0DePuy Mitek2544-00-111-P2025-06-10
B504AS35ULTSTZZ0Conmed Linvatec35ULT-ST-ZZ2017-12-01
B504AS42FRRRAZZ0Conmed Linvatec42FRR-RA-ZZ2017-12-01
B504AS9247A0Conmed Linvatec9247A2017-12-01
B504AS9297A0Conmed Linvatec9297A2017-12-01
B504AS9299A0Conmed Linvatec9299A2017-12-01
B504AS9399A0Conmed Linvatec9399A2017-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044399000NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399017NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399031NES Reprocessed RF Stylet (RFS)NORTH EAST SCIENTIFIC INCNUJ2025-05-21
20888277408743MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
20888277408736MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
B504AEAR98310ArthrexProvisionNUJ2024-09-17
B504CB1381050ConMedProvisionNUJ2024-07-01
B504CBEN60000StrykerProvisionNUJ2024-05-22
B504CBEN70000StrykerProvisionNUJ2024-05-22
00850043377009AquamantysGREEN OR LLCNUJ2024-05-16
00850043377016AquamantysGREEN OR LLCNUJ2024-05-16
00850043377023Aquamantys GREEN OR LLCNUJ2024-05-16
00850043377085AquamantysGREEN OR LLCNUJ2024-05-16
00850043377092Aquamantys GREEN OR LLCNUJ2024-05-16
00850043377108AquamantysGREEN OR LLCNUJ2024-05-16
B504CB138505010ConMedProvisionNUJ2024-04-11
B390138505101Reprocessed MicroNeedle 3cmSURETEK MEDICALNUJ2024-02-20
B390E16511Reprocessed Straight Micro-Needle Electrode, 3cmSURETEK MEDICALNUJ2023-12-15
10080196385331MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277378384MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277379206MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277384408MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277384538MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277386396MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
20888277680415MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
20888277680446MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
20888277719412MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
20888277719436MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
B227RRFS26120NES Reprocessed RF Stylet (RFS)NORTH EAST SCIENTIFIC INCNUJ2023-07-12