FDA.reportPublic FDA data

Leica Keratoscope

Primary DI
07630003570908
Brand
Leica Keratoscope
Company
Leica Microsystems (Schweiz) AG
Model
000000000010448558
Catalog number
10448558
Device description
Leica Keratoscope - Accessory for Leica surgical operating microscope systems
Published
2020-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLQKeratoscope, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLQKeratoscope, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630003570908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630003570908076300035709087630003570908

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, surgicalA mains electricity (AC-powered) ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify minute structures within the eye or its surroundings in the performance of ophthalmic surgical procedures which require high magnification by transmitted light. It is typically equipped with motorized focusing, adjustable magnification mechanisms (zoom), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(847)8213502Andrew.Suchomski@leica-microsystems.com
+1(984)7105152Iris.Pohl@leica-microsystems.com

Regulatory Flags#

DUNS number
480198725
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630802402622ARveo 8000000000010449157 104491572024-05-03
07630802403810MyVeo000000000010449167 104491672024-05-03
07630802403827MyVeo Headset000000000010449164 104491642024-05-02
07630003567717RUV800 WD175000000000010448555 104485552022-08-19
07630003567724Leica RUV800 WD200000000000010448556104485562022-08-19
07630003599008PROVEO 8 F42000000000010449058 104490582020-11-09
07630003598872ARveo 8000000000010449063 104490632021-10-08
07630003552188M220 F12000000000010448367104483672021-06-22
07630003580051Wireless Footswitch 14-functions000000000010448846104488462021-06-15
07630003581034Wireless Footswitch 12-functions000000000010448872 104488722021-06-15
07630003524475M620 Optics Carrier000000000010448294 104482942020-09-22
07630003525243M620 TTS000000000010448213 104482132020-09-22
07630003525472M844 Optics Carrier000000000010448197 104481972020-09-22
07630003526233M844 F40 / M822 F40000000000010448142 104481422020-09-22
07630003526295M822 C40 / M822 CT40 / M844 C40 / M844 CT40000000000010448140 104481402020-09-22
07630003551907M525 F20000000000010448284104482842020-09-22
07630003551914M525 Optics Carrier000000000010448300 104483002020-09-22
07630003552195M620 F20000000000010448380104483802020-09-22
07630003568707M822 Optics Carrier000000000010448587104485872020-09-22
07630003581799PROVEO 8 Optics Carrier000000000010448800 104488002020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09349221000033Medmont Corneal Topographer E300 USBMEDMONT INTERNATIONAL PTY LTDHLQ2022-09-14
04987669101476AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2019-02-22
06945033902010TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HLQ2018-09-24
06945033902027TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HLQ2018-09-24
04987669100714AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2018-04-20
04987669100721AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2018-04-20
04987669100745AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2018-04-20
04987669100769HANDHELD REF / KERATOMETERNIDEK CO.,LTD.HLQ2018-04-20
00869228000472IBEX Keratometer Trevi Technology, Inc.HLQ2018-01-01
04049584000217Park 1OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLQ2016-09-01
04987669100776REFRACTIVE POWER / CORNEAL ANALYZERNIDEK CO.,LTD.HLQ2016-08-19
04987669100738AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2016-08-10
04987669100066AUTO REF/KERATO/TONOMETERNIDEK CO.,LTD.HLQ2016-06-24