FDA.report

Olympus

Primary DI
14953170142014
Brand
Olympus
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
K-010
Device description
DISPOSABLE EMR KIT
Published
2018-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FDSGastroscope and accessories, flexible/rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14953170142014PackageGS11In Commercial Distribution
04953170142017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1495317014201414953170142014
04953170142017049531701420174953170142017

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical 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 may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags

DUNS number
711789789
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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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

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