FDA.reportPublic FDA data

MediWorks

Primary DI
06945087526019
Brand
MediWorks
Company
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Model
S260
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152429000Slit Lamp MicroscopeShanghai Mediworks Precision Instruments Co. , Ltd.2016-05-11HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945087526019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945087526019069450875260196945087526019

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527884077
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945087500262MediWorksDM3902026-10-09
06945087500439EssilorDS6502026-10-09
06945087565018EssilorSL6502022-11-02
06945087500057EssilorSL650+2022-11-02
06945087520000RodenstockRSL 21002021-05-17
06945087525005RodenstockRSL 26002021-05-17
06945087525012RodenstockRSL 2600digital2021-05-17
06945087590003TomeyTSL-900Z2021-05-17
06945087590010TomeyTSL-900H2021-05-17
06945087590027TomeyTSL-900Hdigital2021-05-17
06945087540015EssilorSL400H2021-05-10
06945087540022EssilorSL400L2021-05-10
06945087545010EssilorSL450H2021-05-10
06945087545027EssilorSL450L2021-05-10
06945087505175MediworksScansys TA5172020-03-12
06945087516225MediworksFC1622021-05-18
06945087500026MediworksSM6212022-11-02
06945087500040MediWorksS2902022-11-02
06945087500217MediWorksSL6502022-11-02
06945087515013MediworksS1502022-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04562123289602SLIT LAMP SL-D4 (Type:LED)TOPCON CORPORATIONHJO2026-09-28
0695109080097866VT66 VISION TECH CO., LTD.HJO2026-04-27
04250668607202VISUREF 600Carl Zeiss Vision GmbHHJO2026-04-24
04049471097153SL 220Carl Zeiss Meditec AGHJO2026-01-13
00852194002137SL-5000Hightech American Industrial Labs IncHJO2025-12-18
04547451338321INAMIINAMI & CO., LTD.HJO2025-08-29
00819034023240TalarLiftFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520738PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520745PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520752PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520769PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520776PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520783PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520790PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520806IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520813IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520820LapiLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520837DynaBridgeFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520844DynaBridgeFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520851Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520868Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520875LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520882Sgarlato SilasticFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520905PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520912PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520929PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520936PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007346Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007353Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
04987646810476KOWA SL-19KOWA COMPANY,LTD.HJO2024-10-08