FDA.reportPublic FDA data

Single Use Rotatable Clip Fixing Device

Primary DI
04953170353123
Brand
Single Use Rotatable Clip Fixing Device
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
HX-201UR-135
Catalog number
N4541030
Device description
Single Use Rotatable Clip Fixing Device
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
14953170353120PackageGS15In Commercial Distribution
54953170353128PackageGS112Not in Commercial Distribution
04953170353123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317035312014953170353120
5495317035312854953170353128
04953170353123049531703531234953170353123

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

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
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