FDA.reportPublic FDA data

Motorized Instrument Table

Primary DI
04712826770697
Brand
Motorized Instrument Table
Company
LIGHTMED CORPORATION
Model
TB0013
Published
2017-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRJTable, Instrument, Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRJTable, Instrument, Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712826770697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712826770697047128267706974712826770697

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic instrument table, line-poweredA mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient's eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight57Kilogram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657731175
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712826770680LightMed TruScan 577ML00152016-09-23
04712826770642LightLas 577YC00102016-09-23
04712826770772TruScan ProTP0001 (532/577/670/810)2019-07-08
04712826770789TruScan ProTP00022019-07-08
04712826770796TruScan ProTP00032019-07-08
04712826770802TruScan ProTP00042019-07-08
04712826770819TruScan ProTP00052019-07-08
04712826770826TruScan ProTP00062019-07-08
04712826770833TruScan ProTP00072019-07-08
04712826770840TruScan ProTP00082019-07-08
04712826770857TruScan ProTP00092019-07-08
04712826770864TruScan ProTP00102019-07-08
04712826770871TruScan ProTP00112019-07-08
04712826770888TruScan ProTP00122019-07-08
04712826770970TruScan ProTP00132020-04-08
04712826770987TruScan ProTP00162020-04-08
04712826770994TruScan ProTP00212020-04-08
04712826771007TruScan ProTP00222020-04-08
04712826770635LightLas 810LD00102016-09-23
04712826770659LightLas 532/670ML00102016-09-23

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