FDA.reportPublic FDA data

Clement Clarke Ophthalmic

Primary DI
05060179470313
Brand
Clement Clarke Ophthalmic
Company
HAAG-STREIT UK LIMITED
Model
5606013 US
Catalog number
5606013 US
Device description
BA904 SLIT LAMP SET C (05)
Published
2016-07-22
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
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953965000904 SLIT LAMPClement Clarke, Inc.1995-09-27HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060179470313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060179470313050601794703135060179470313

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-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
+4401279414969twhay@ccholdingsltd.com

Regulatory Flags#

DUNS number
504108242
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056158000718Haag-Streit UK730900373090032022-11-23
05056158001807Haag-Streit UK730900173090012022-11-23
05056158001814Haag-Streit UK730900273090022022-11-23
05055296017497Haag Streit John Weiss010707301070732022-11-22
05056158000664Clement Clarke Ophthalmic700400170040012022-11-22
05060179470023Clement Clarke Ophthalmic6401001ULUS6401001ULUS2016-07-22
05060179470030Clement Clarke Ophthalmic6402001ULUS6402001ULUS2016-07-22
05060179470078Clement Clarke Ophthalmic580500158050012016-07-22
05060179470146Clement Clarke Ophthalmic6403001ULUS6403001ULUS2016-07-22
05060179470276Clement Clarke Ophthalmic5606011 US5606011 US2016-07-22
05060179470344Clement Clarke Ophthalmic6908000US6908000US2016-07-22
05060179470375Clement Clarke Ophthalmic700600170060012016-08-05
05060179470399Clement Clarke Ophthalmic700500170050012016-08-12
05060179470559Haag Streit UK580510058051002016-07-22
05060179470726Haag Streit UK470100147010012016-07-22
05056158000817Haag-Streit UK730900373090032022-11-23
05056158000220Haag-Streit UK730900173090012022-11-23
05056158000701Haag-Streit UK730900273090022022-11-23

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