FDA.reportPublic FDA data

Luedde Exophthalmometer

Primary DI
B091161040
Brand
Luedde Exophthalmometer
Company
Gulden Ophthalmics Inc.
Model
1
Published
2022-11-28
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
B091161040PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002373249
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B091230122Silicone Suction Cup (10pk)2230122024-09-04
B091230120Silicone Suction Cup (10pk)2230122024-09-04
B091230121Silicone Suction Cup (12 pk)12023-07-05
B09114150010mm Eye Sphere (non-sterile)14150141502023-07-19
B09114151012mm Eye Sphere (non-sterile)14151141512023-07-19
B09114152014mm Eye Sphere (non-sterile)14152141522023-07-19
B09114153016mm Eye Sphere (non-sterile)14153141532023-07-19
B09114154018mm Eye Sphere (non-sterile)14154141542023-07-19
B09114155020mm Eye Sphere (non-sterile)14155141552023-07-19
B09114156022mm Eye Sphere (non-sterile)14156141562023-07-19
B091112000Tangent Screen12023-07-05
B091121270Clip-on Multiple Pinhole Occluder12023-07-05
B091121280Clip-on Occluder12023-07-05
B091121310Clip-on Spielmann12023-07-05
B091151320Peds Pack12023-07-05
B091151330Brock String12023-07-05
B091151600Retinoscopy Rack with Compass12023-07-05
B091151610Retinoscopy Rack12023-07-05
B091151760Color Fixation Sticks12023-07-05
B091152030Flashing Butterfly Fixation Stick12023-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
04049584007599Mirror Exophthalmometer acc. to NaugleOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLS2022-12-02
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