Reusable guide

GUDID 03665134000059

The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. Sold *5

KOELIS

Nonimplantable needle guide, single-use

Primary Device ID	03665134000059
NIH Device Record Key	f4c7db27-f955-4752-b60e-83725d80ba81
Commercial Distribution Status	In Commercial Distribution
Brand Name	Reusable guide
Version Model Number	GPK490-5
Company DUNS	290318455
Company Name	KOELIS
Device Count	5
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter
Length	161.5 Millimeter
Width	40 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665134000042 [Unit of Use]
GS1	03665134000059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141334

FDA Product Code

ITX	Transducer, Ultrasonic, Diagnostic