FDA.report

HEINE BETA® 200 F.O. Otoscope

Primary DI
04053755190836
Brand
HEINE BETA® 200 F.O. Otoscope
Company
Heine Optotechnik GmbH & Co. KG
Model
166
Catalog number
B-002.11.500
Published
2017-11-03
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
ERAOtoscope

Product Code Classifications

CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04053755190836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04053755190836040537551908364053755190836

GMDN Terms

TermDefinition
General physical examination setA collection of hand-held devices, battery-powered but may include manual, intended to be used by a physician to help perform parts of a general physical examination of a patient [i.e., ear/nose/throat (ENT) and ophthalmic examinations, blood pressure measurements, temperature] commonly conducted in a primary care setting. The devices (e.g., aneroid sphygmomanometer, otoscope, ophthalmoscope, electronic thermometer) are typically housed within a line-powered charging station (e.g., desktop, wall-mounted) or carry case, which may include accessories (e.g., ear specula, spare light bulbs). This is a reusable device that may contain some disposable devices.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)643-6275support@midmark.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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04053755136995GAMMA 3.2000M-000.09.9422022-12-12
04053755137015GAMMA 3.3000M-000.09.9432022-12-12
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