FDA.report

CS 1500

Primary DI
60889976559802
Brand
CS 1500
Company
CARESTREAM HEALTH, INC.
Model
CS 1500
Catalog number
6559801
Device description
CS1500 INTRA ORAL CAMERA WIRELESS
Published
2016-09-16
Public version status
Update
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

Product Codes

CodeName
EIAUNIT, OPERATIVE DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
60889976559802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
6088997655980260889976559802

GMDN Terms

TermDefinition
Flexible video stomatoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the oral cavity. It is inserted into the mouth during a dental procedure. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
793169512
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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