FDA.reportPublic FDA data

Single Use Repositionable Clip

Primary DI
04953170385940
Brand
Single Use Repositionable Clip
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
HX-202UR
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKLHemostatic metal clip for the GI tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170385947PackageGS15In Commercial Distribution
04953170385940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317038594714953170385947
04953170385940049531703859404953170385940

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
04953170421594HD CAMERA HEADCH-S200-08-LBN61317402026-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664915998NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916001NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916018NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916025NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916032NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916049NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916056NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916063NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916070NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916087NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916148NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916155NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916162NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916179NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916186NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916193NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916209NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916216NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916223NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916230NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916247NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916254NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916261NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916278NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916285NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916377NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916384NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916391NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916407NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916414NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31