FDA.report

Mirror Exophthalmometer acc. to Naugle

Primary DI
04049584007599
Brand
Mirror Exophthalmometer acc. to Naugle
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
52401
Device description
Mirror Exophthalmometer acc. to Naugle
Published
2022-12-02
Public version status
New
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

Product Codes

CodeName
HLSExophthalmometer

Product Code Classifications

CodeDeviceSpecialtyClass
HLSExophthalmometerOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049584007599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049584007599040495840075994049584007599

GMDN Terms

TermDefinition
ExophthalmometerAn ophthalmic instrument used to measure the degree of exophthalmos (abnormal protrusion of the eyeball). It may be designed in the form of a ruler, gauge, or calliper. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
317138956
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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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