HEINE OMEGA 180

Primary DI
00192896009486
Brand
HEINE OMEGA 180
Company
SONTEC INSTRUMENTS, INC.
Model
C-004.33.226
Catalog number
C-004.33.226
Device description
HEINE - OMEGA 180 WITH EN15 AND TRANSFORMER
Published
2018-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJILens, Fundus, Hruby, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJILens, Fundus, Hruby, DiagnosticOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123316000HEINE OMEGA 500Heine Optotechnik GmbH & Co. KG2013-02-26HLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896009486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896009486001928960094861928960094860192896009486

GMDN Terms#

Term, Definition table
TermDefinition
Indirect binocular ophthalmoscope, line-poweredA mains electricity (AC-powered), ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. It typically consists of a main light to illuminate the interior of the eyeball, a system of lenses and filters and an illuminator beam to eliminate reflexes. Also called a binocular indirect ophthalmoscope (BIO), it produces images that better overcome large refractive errors and subtle colour differences. It can be mounted on a headband or spectacle frames and the power is run through a transformer to reduce this to low-voltage.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Lot or batch
true
Sterilization required before use
true

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00192896094567ROCHESTER CARMALT FORCEPS1100-150Q1100-150Q2019-03-07
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00192896041042ETHMOID PEDIATRIC RONGEUR468-590468-5902018-09-10
00192896041059WILDE ETHMOID RONGEUR468-600468-6002018-09-10
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00192896041073WILDE ETHMOID RONGEUR468-610468-6102018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07612717071285Alcon GrieshaberAlcon Laboratories, Inc.HJI2020-08-19
17612717071282Alcon GrieshaberAlcon Laboratories, Inc.HJI2020-08-19
00192896009493HEINE OMEGA 180SONTEC INSTRUMENTS, INC.HJI2018-08-15
00811608012476TransEquator (VTE)VOLK OPTICAL INC.HJI2016-09-29
00811608012483PDT Laser (VPDT)VOLK OPTICAL INC.HJI2016-09-29