FDA.reportPublic FDA data

Contact glass 902 S

Primary DI
07640132986303
Brand
Contact glass 902 S
Company
Haag-Streit AG
Model
902 S
Catalog number
1400276
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051103000HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYHaag-Streit USA, Inc.2005-06-07HJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640132986303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640132986303076401329863037640132986303

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic condensing lensAn ophthalmic lens used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) to focus reflected light from the fundus of the eye. Compared to direct ophthalmosocoy, the indirect method enables better viewing of the peripheral region of the fundus out to the ora serrata (serrated junction between the retina and the ciliary body).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41319780111service@haag-streit.com

Regulatory Flags#

DUNS number
483467544
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640132988956Metis 900400201040020102025-02-06
07640132987935HS Hi-R NEO 900 MicroscopeHS Hi-R NEO 9002023-06-13
07640132987942HS Hi-R NEO 900 MicroscopeHS Hi-R NEO 900A2023-06-13
07640132987959NEO 900 HS MIOS 5HS MIOS 52023-06-13
07640132988017HS NEO 900 CarrierFS 2-252023-06-13
07640132985610Imaging SetBI 90072205352022-11-22
07640132986549HeadrestWith Lower Part10215542022-11-22
07640132986556HeadrestWith Lower Part RAL 703514201812022-11-22
07640132986563HeadrestWith Lower Part Silver14201822022-11-22
07640132986570HeadrestWith Lower Part RAL 900514201832022-11-22
07640132986600HeadrestWith Lower Part Silver14201862022-11-22
07640132986617HeadrestWith Lower Part for RAL 703514201872022-11-22
07640132986655HeadrestWith Lower Part for adapter RAL 703514201912022-11-22
07640132986679HeadrestFor Pendulum Table RAL 703514201932022-11-22
07640132986686HeadrestFor Pendulum Table Silver14201942022-11-22
07640132986747HeadrestWith Lower Part for adapter RAL 703514202002022-11-22
07640132986754HeadrestWithout lower Silver14202012022-11-22
07640132986761HeadrestWithout lower RAL 703514202022022-11-22
07640132986778HeadrestWithout lower Silver14202032022-11-22
07640132986785HeadrestWithout lower RAL 703514202042022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668123942KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144466KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144473KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668123949KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144463KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144470KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00818806021774RxSight Contact LensRXSIGHT, INC.HJK2025-09-05
00811608014869Capsulotomy (VLUCAPS)VOLK OPTICAL INC.HJK2025-01-29
00811608015934Iridectomy (VLUIRID)VOLK OPTICAL INC.HJK2025-01-29
00856222004209SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
10856222004206SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
00811608014654Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
10811608014675Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
03760087122343SINGLE USE 3 MIRRORS CONTACT LENSFCI S A S FCI 20 22HJK2021-05-30
00852475007202"Contact Lens, HD Professional, Cohen-Benner, ""CBC"""OCULUS SURGICAL INCHJK2021-02-26
10852475007209Contact Lens, HD Professional, Cohen-Benner, "CBC"OCULUS SURGICAL INCHJK2021-02-26
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00852475007059SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00818806020531RxSight Contact LensRXSIGHT, INC.HJK2020-10-16
03760087122176Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122190Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122206Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122213Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123685Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123692Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123708Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122171Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122195Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122201Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122218Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06