FDA.reportPublic FDA data

Headrest

Primary DI
07640132986792
Brand
Headrest
Company
Haag-Streit AG
Model
Without lower Silver
Catalog number
1420205
Published
2022-11-22
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
PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUEBiomicroscope, Slit-Lamp, Ac-Powered, ExemptOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640132986792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640132986792076401329867927640132986792

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
483467544
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
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
06975449020022SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020039SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020046SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06973211070930Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070947Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070954Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070961Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070978Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070985Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
00860010833209ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833247ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833261ILLUMINIXIlluminix Industries LLCPUE2024-01-23
08908006463497LABOMED SLx 40- 3 Step Slit lamp -HL (Halogen)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463503LABOMED SLx 45- 3 Step Slit lamp -HL(Halogen)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463510LABOMED SLx 40- 3 Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463527LABOMED SLx 45- 3 Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463534LABOMED eVO300 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463541LABOMED eVO400 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463558LABOMED eVO300 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463565LABOMED eVO400 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463589LABOMED eVO450 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463596LABOMED eVO350 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463602LABOMED eVO450 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
06972039971405MOPTIMShenzhen CERTAINN Technology Co., Ltd.PUE2022-12-08
07640132985610Imaging SetHaag-Streit AGPUE2022-11-22
07640132986549HeadrestHaag-Streit AGPUE2022-11-22
07640132986556HeadrestHaag-Streit AGPUE2022-11-22
07640132986563HeadrestHaag-Streit AGPUE2022-11-22
07640132986570HeadrestHaag-Streit AGPUE2022-11-22