FDA.reportPublic FDA data

Smith and Nephew

Primary DI
08100416312475
Brand
Smith and Nephew
Company
Provision
Model
EICA9820-01
Published
2019-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172647000Reprocessed ArthroCare ENT CoblatorRenovo, Inc.2018-02-21NUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08100416312475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08100416312475081004163124758100416312475

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016889401
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
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
B504OM50711330ConMed Linvatec5071-1332026-02-24
B504OM50721010ConMed Linvatec5072-1012026-02-24
B504OMBR58201070250BrasselerBR5820-107-0252026-02-24
B504OMPDS2NL300NakanishiPDS-2NL-302026-02-09
B504OM13090119XG10Zimmer13090119XG12025-11-25
B504OM19100119XG10Zimmer19100119XG12025-11-25
B504OM20090119XC10Zimmer20090119XC12025-11-25
B504OM20100119XC10Zimmer20100119XC12025-11-25
B504OM20100119XCW0Zimmer20100119XCW2025-11-25
B504OM21090119XGW0Zimmer21090119XGW2025-11-25
B504AE2273010DePuy Mitek 2273012018-04-05
B504AE2273020DePuy Mitek 2273022018-04-05
B504AE2273050DePuy Mitek 2273052018-04-05
B504CBEICA5874010Smith & NephewEICA5874-012018-04-03
B504CBEICA8875010Smith & NephewEICA8875-012018-04-03
B504CBEICA8898010Smith & NephewEICA8898-012018-04-03
B504EICA9820010Smith & NephewEICA9820-012019-03-19

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
10888277408746MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
20888277408743MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
10888277408739MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
20888277408736MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
10888277325227MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277391987MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277414907MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680326MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680333MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680340MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680357MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680371MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680395MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680432MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719330MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719354MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719378MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719392MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
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
00850043377085AquamantysSTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2024-05-16