FDA.reportPublic FDA data

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

Product Codes#

Code, Name table
CodeName
HLSExophthalmometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLSExophthalmometerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049584007599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584007599040495840075994049584007599

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
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 table
Method

Regulatory Flags#

DUNS number
317138956
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049584034953Pentacam Cornea OCT100190012026-03-31
04049584037909Cable SDI BIOM 6 for Alcon LuxOR Revalia100401382026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900100401372026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8x100413192026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8x100432282026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevalia100425572026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLuma100428332026-02-11
04049584037695Focusing Module BIOM 6, 175 mm100351102026-01-23
04049584037701Focusing Module BIOM 6, 200 mm100379072026-01-23
04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035714BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584037152BIOM 6100348202026-01-14
04049584037251Twinfield 3100348192026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732094140323Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-23
00732094140576Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-23
00732094139266Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094139341Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094139365Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094139969Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094140293Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094140309Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094077599Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-17
00732094077636Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-17
00732094078572Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-17
00732094078596Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-17
04049584007582Mirror Exophthalmometer acc. to HertelOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLS2022-12-02
B091161040Luedde ExophthalmometerGulden Ophthalmics Inc.HLS2022-11-28
00732094139389Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-12-08
00732094336740Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-12-08
00732094338409Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338416Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338423Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338430Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338447Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338454Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338461Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338478Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094248937Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-03
00732094138979Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-06-18
00732094139884Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-06-18
00732094078541Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-01-16
00732094139754Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-01-16
00732094139792Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-01-16