FDA.reportPublic FDA data

Haag Streit UK

Primary DI
05060179470726
Brand
Haag Streit UK
Company
HAAG-STREIT UK LIMITED
Model
4701001
Catalog number
4701001
Device description
SCHIRMER TEAR TEST, PACK OF 50
Published
2016-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYDStrip, Schirmer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYDStrip, SchirmerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060179470726PrimaryGS10
05060179470825Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060179470726050601794707265060179470726
05060179470825050601794708255060179470825

GMDN Terms#

Term, Definition table
TermDefinition
Schirmer tear test stripAn ophthalmic device in the form of a small absorbent strip, made of filter paper or similar material, that is manually inserted under the patient's lower eyelid for a period of time to stimulate and evaluate the formation of tears. Commonly known as the Schirmer's test (ST), the device is used to provide a rapid lacrimal assessment for tearflow or tear volume. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
504108242
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
05060179470399Clement Clarke Ophthalmic700500170050012016-08-12
05060179470559Haag Streit UK580510058051002016-07-22
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
00841668114841Color Bar Schirmer Tear TestKATENA PRODUCTS, INC.KYD2023-07-06
10841668114848Color Bar Schirmer Tear TestKATENA PRODUCTS, INC.KYD2023-07-06
14582495170145SMTubeECHO ELECTRICITY CO.,LTD.KYD2020-07-25
24582495170142SMTubeECHO ELECTRICITY CO.,LTD.KYD2020-07-25