FDA.reportPublic FDA data

SINGLE USE LIGATING DEVICE

Primary DI
04953170368615
Brand
SINGLE USE LIGATING DEVICE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
HX-400U-30
Catalog number
N5382130
Published
2016-09-21
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
MNDLigator, Esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNDLigator, EsophagealGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170368612PackageGS15In Commercial Distribution
54953170368610PackageGS110Not in Commercial Distribution
04953170368615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317036861214953170368612
5495317036861054953170368610
04953170368615049531703686154953170368615

GMDN Terms#

Term, Definition table
TermDefinition
Polypectomy endoscopic ligator, single-useA device used in combination with a compatible flexible endoscope for the deployment of a ligature loop (a self-locking device made of, e.g., a polymer in the form of a thin band) that is typically applied to large colorectal or pedunculated polyps in the gastrointestinal (GI) tract to prevent or control bleeding following polypectomy. It typically consists of an insertion sheath, the ligature loop at the distal end, and a control handle at the proximal end used to deploy the loop. This device may be used to ligate the appendix during its removal. 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
Premarket exempt
true
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
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8019N62211302025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8022N62213302025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8025N62215302025-12-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503532853Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532860Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532877Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532884Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532891Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532907Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532914Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532938Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532945Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532921Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-01-30
06923646508645Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508652Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508669Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508676Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508683Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508690Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508706Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508713Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508720Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508744Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508638Ligation DeviceLeo Medical Co., Ltd.MND2025-12-18
06923646508737Ligation DeviceLeo Medical Co., Ltd.MND2025-12-18
00724995247331SmartBand SafeGrip Multi-Band Ligation KitUS EndoscopyMND2025-11-21
00724995247348SmartBand SafeGrip Multi-Band Ligation PackUS EndoscopyMND2025-11-21
00724995247355SmartBand Ligation KitUS EndoscopyMND2025-11-21
00724995247362SmartBand Ligation PackUS EndoscopyMND2025-11-21
16934415066621ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066638ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066645ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066652ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06