FDA.reportPublic FDA data

LABOMED eVO450 5-Step Slit lamp -Halogen (HL)

Primary DI
08908006463589
Brand
LABOMED eVO450 5-Step Slit lamp -Halogen (HL)
Company
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Model
8127300
Published
2023-06-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUEBiomicroscope, Slit-Lamp, Ac-Powered, ExemptOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908006463589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006463589089080064635898908006463589

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic examination slit lampAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Regulatory Flags#

DUNS number
919049606
Device count
1
DM exempt
true
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906168451536Prima Swift surgical Microscope61825052026-07-19
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)81263002023-06-17
08906168451499Prima Lite Surgical Microscope61815012026-07-19
08906168451505Prima Lite Surgical Microscope Wall mount61815022026-07-19
08906168451512Prima Lite ENT Surgical Microscopes61825042026-07-19
08906168451529Prima Lite trainer61825122026-07-19
08906168451543Prima Pro surgical Microscope61836012026-07-19
08906168451550Prima Pro surgical Microscope61836032026-07-19
08906168451567Prima Floor Stand with Column6182001-8712026-07-19
08908006463022Labomed Prima DNT Microscope Mobile Mount61380002022-12-12
08908006463046Labomed Prima DNT Microscope Wall mount61371012022-12-13
08908006463053Labomed Prima DNT Microscope Ceiling Mount61372012022-12-13
08908006463060Labomed Prima DNT Microscope Table Mount61675002022-12-13
08908006463077Labomed Prima DNT Microscope Wall mount long arm61371022022-12-13
08908006463084Labomed Prima DNT Microscope Ceiling Mount Long Arm61372022022-12-13
08908006463091Labomed Prima DNT Microscope Floor Mount Fixed61380012022-12-13
08908006463107Labomed Prima DNT Microscope Floor Mount Fixed Long Arm61380022022-12-13
08908006463114Labomed Magna Floor stand standard arm Microscope61291002022-12-13
08908006463121Labomed Magna Ceiling mount (Standard Arm)61292002022-12-13
08908006463138Labomed Magna Wall mount (Standard Arm)61293002022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975449020022SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020039SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020046SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06973211070930Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070947Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070954Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070961Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070978Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070985Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
00860010833209ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833247ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833261ILLUMINIXIlluminix Industries LLCPUE2024-01-23
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08908006463503LABOMED SLx 45- 3 Step Slit lamp -HL(Halogen)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
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08908006463527LABOMED SLx 45- 3 Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
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08908006463541LABOMED eVO400 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463558LABOMED eVO300 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463565LABOMED eVO400 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463596LABOMED eVO350 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463602LABOMED eVO450 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
06972039971405MOPTIMShenzhen CERTAINN Technology Co., Ltd.PUE2022-12-08
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07640132986556HeadrestHaag-Streit AGPUE2022-11-22
07640132986563HeadrestHaag-Streit AGPUE2022-11-22
07640132986570HeadrestHaag-Streit AGPUE2022-11-22
07640132986600HeadrestHaag-Streit AGPUE2022-11-22