FDA.report

KLARO In Vivo Surgical Lighting

Primary DI
08881300212018
Brand
KLARO In Vivo Surgical Lighting
Company
VIVO SURGICAL PRIVATE LIMITED
Model
555-01-01
Catalog number
555-01-01
Device description
KLARO is a deep-cavity surgical LED lighting device for open surgery use. It is discreet, easy to use and provides bright, uniform and localised "flood-lighting" from within the surgical site. KLARO maintains a safe and cool working temperature suited for use inside the human body regardless of the luminous intensity selected.
Published
2023-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FTDLamp, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08881300212018PackageGS15In Commercial Distribution
08881300212025PackageGS12In Commercial Distribution
08881300212001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08881300212018088813002120188881300212018
08881300212025088813002120258881300212025
08881300212001088813002120018881300212001

GMDN Terms

TermDefinition
Open surgical site internal lightAn electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+6566770395regulatory@vivo-surgical.com

Regulatory Flags

DUNS number
659504181
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

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