FDA.reportPublic FDA data

Clement Clarke Ophthalmic

Primary DI
05060179470399
Brand
Clement Clarke Ophthalmic
Company
HAAG-STREIT UK LIMITED
Model
7005001
Catalog number
7005001
Device description
MADDOX WING TEST
Published
2016-08-12
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
HKWPrism, Bar, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKWPrism, Bar, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060179470399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060179470399050601794703995060179470399

GMDN Terms#

Term, Definition table
TermDefinition
Maddox trial lensA special ophthalmic trial lens in the form of a rod or series of rods (grooves/cylinders) that changes the size, shape, and colour of an image to dissociate the eyes in the evaluation of eye muscle dysfunction [method to evaluate the alignment or deviation (i.e., heterophoria or heterotropia) of a pair of eyes]. The device is usually made of red glass and intended to be hand-held or placed in a trial frame.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401279414969twhay@ccholdingsltd.com

Regulatory Flags#

DUNS number
504108242
Device count
1
Premarket exempt
true
Lot or batch
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
05060179470313Clement Clarke Ophthalmic5606013 US5606013 US2016-07-22
05060179470344Clement Clarke Ophthalmic6908000US6908000US2016-07-22
05060179470375Clement Clarke Ophthalmic700600170060012016-08-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00360843010490OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010506OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010513OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010520OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010537OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010544OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010551OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010568OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010575OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010582OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010599OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010605OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010612OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010629OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010636OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010643OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010650OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010667OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010674OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010681OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010230OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010247OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010254OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010261OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010278OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010285OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010292OptegoOptego Vision USA Inc.HKW2023-11-01