FDA.report

HEINE OMEGA®500

Primary DI
04053755188468
Brand
HEINE OMEGA®500
Company
Heine Optotechnik GmbH & Co. KG
Model
L
Catalog number
C-004.33.536
Published
2016-09-24
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

Contact Domains

Product Codes

CodeName
HLJOphthalmoscope, Battery-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04053755188468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04053755188468040537551884684053755188468

GMDN Terms

TermDefinition
Indirect binocular ophthalmoscope, battery-poweredA battery-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; the batteries may be incorporated, or the power supplied via an electrical cable from an external battery pack.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 (603) 742-7103service@heine-na.com

Regulatory Flags

DUNS number
315274563
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

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00732094357943Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-03-27
10193489136241MEDLINEMEDLINE INDUSTRIES, INC.HLJ2024-11-28
10193489136210MEDLINEMEDLINE INDUSTRIES, INC.HLJ2024-09-09
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00850038195335Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
00850038195342Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
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00810149090745R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
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