CoreLite

Primary DI: 05060508820017
Company: CIRDAN IMAGING LIMITED
Model: 1
Device description: X-ray specimen cabinet
Published: 2020-03-31
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: false

Related Records

Regulatory Flags

DUNS number: 216744109
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: false
Serial number: true
Manufacturing date on label: true
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Identifiers

Identifier	Type	Agency	Package quantity	Status
05060508820017	Primary	GS1	0

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Package type	Contains DI	Discontinue date	Status
05060508820017	Primary	GS1	0

Product Codes

Code	Name	Class	Specialty	Regulation	Implant	Malfunction reporting
MWP	Cabinet, X-Ray System	2	Radiology	892.1680	N	Eligible

Premarket Submissions

Submission	Supplement
K193317	000

Premarket Details

Submission	Supplement	Device	Applicant	Decision date	Product code
K193317	000	CoreLite X-Ray Specimen Cabinet	Cirdan Imaging Limited	2019-12-13	MWP

GMDN Terms

Term	Definition
Specimen x-ray system IVD	An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.

Term

Definition

Specimen x-ray system IVD

An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

Phone	Email
+442892660880	jmcgarry@cirdan.com

Other Devices From This Company

Primary DI	Brand	Model	Catalog	Published
05060508820000	Pathnet Blood Bank Transfusion (L-2300)	4.1		2016-11-21

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