FDA.reportPublic FDA data

Single Use Electrosurgical Snare SD-400

Primary DI
04953170408250
Brand
Single Use Electrosurgical Snare SD-400
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
SD-400U-15
Catalog number
N5998330
Published
2020-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDISNARE, FLEXIBLE
FGXSNARE, NON-ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2
FGXSnare, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170408257PackageGS110In Commercial Distribution
54953170408255PackageGS110Not in Commercial Distribution
04953170408250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317040825714953170408257
5495317040825554953170408255
04953170408250049531704082504953170408250

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a 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 requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421457SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421464SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421471SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421488SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
46932503554518EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
46932503554525EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
00724995247317SmartBand EMR KitUS EndoscopyFDI2025-11-21
00724995247324SmartBand EMR PackUS EndoscopyFDI2025-11-21
00724995243753Exacto MundoUS EndoscopyFGX2025-08-19
00724995243760Exacto MundoUS EndoscopyFGX2025-08-19
00724995243746Exacto MundoUS EndoscopyFGX2025-01-31
00724995220051Roth NetUS EndoscopyFDI2024-11-25
00724995220068Roth Net PlatinumUS EndoscopyFDI2024-11-25
00816207021324RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021331RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021348RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021355RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021362RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021379RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207020969eSuctionENDO-THERAPEUTICS, INC.FGX2022-09-21
00816207020976eSuctionENDO-THERAPEUTICS, INC.FGX2022-09-21
00816207021089SwirlNetENDO-THERAPEUTICS, INC.FGX2022-09-21
00816207021096SwirlNetENDO-THERAPEUTICS, INC.FGX2022-09-21
00816207021102SwirlNetENDO-THERAPEUTICS, INC.FGX2022-09-21
00816207021119SwirlNetENDO-THERAPEUTICS, INC.FGX2022-09-21
00816207021126SwirlNetENDO-THERAPEUTICS, INC.FGX2022-09-21
00724995182557ExactoUS EndoscopyFGX2021-03-31
00724995182564ExactoUS EndoscopyFGX2021-03-31
00724995182618ExactoUS EndoscopyFGX2021-03-31
20653405054129NAKAOConmed CorporationFGX2020-09-24