FDA.reportPublic FDA data

Rotatable Clip Fixing Device

Primary DI
14953170200202
Brand
Rotatable Clip Fixing Device
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
HX-110QR
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
14953170200202PackageGS11In Commercial Distribution
04953170200205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317020020214953170200202
04953170200205049531702002054953170200205

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA sterile, 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
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
14953170467377SINGLE USE DISTAL COVERMAJ-2315N61920012026-03-06
04953170467288ULTRASONIC PROBEUM-3R-3N53871402026-01-21
04953170467318ULTRASONIC PROBEUM-G20-29R-3N53872402026-01-21
14953170466219Single Use Cytology Brush VBC-V600P-3010N36258402026-01-19
14953170466349Single Use 3-Lumen Needle Knife VKD-V441MN54207402025-12-18
14953170466356Single Use 3-Lumen Needle Knife VKD-V451MN54208402025-12-18
04953170465277AUXILIARY WATER TUBEMAJ-855N34993402025-12-05
04953170421815Reusable Cordless TransducerTD-410N61329402025-12-04
14953170439992THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cmTB2-0520FCR50010082025-12-04
14953170440004THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cmTB2-0525FCR50010092025-12-04
14953170440011THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cmTB2-0535FCR50010102025-12-04
14953170440028THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cmTB2-0545FCR50010112025-12-04
04953170442353ULTRASONIC BIPOLAR GENERATORUSG-410N61924402025-12-04
04953170442445Update Tool for USG-410MAJ-2467N61925402025-12-04
14953170459204Single-use Fine Needle Biopsy (FNB) Device NA-U210HNA-U210H-8019N62211302025-12-02
14953170459259Single-use Fine Needle Biopsy (FNB) Device NA-U210HNA-U210H-8022N62213302025-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16934415066669ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066676ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
14953170462396Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
14953170462426Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
14953170462488Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
14953170462549Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
06934415023191ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023207ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023214ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023221ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023115ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023122ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023139ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023146ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023153ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023160ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023177ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023184ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023023ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023030ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023047ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023054ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023061ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023078ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023085ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023092ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28