FDA.reportPublic FDA data

Color Bar Schirmer Tear Test

Primary DI
00841668114841
Brand
Color Bar Schirmer Tear Test
Company
KATENA PRODUCTS, INC.
Model
0039
Catalog number
0039
Device description
(50 Pouches)
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
00841668114841PrimaryGS10
10841668114848Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668114841008416681148418416681148410841668114841
1084166811484810841668114848

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.

Regulatory Flags#

DUNS number
085668598
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668146460BarronK20-2165K20-21652026-06-10
00841668146484BarronK20-2167K20-21672026-06-10
00841668146491BarronK20-2170K20-21702026-06-10
00841668146507BarronK20-2172K20-21722026-06-10
00841668146514BarronK20-2175K20-21752026-06-10
00841668146521BarronK20-2177K20-21772026-06-10
00841668146538BarronK20-2180K20-21802026-06-10
00841668146545BarronK20-2182K20-21822026-06-10
00841668146552BarronK20-2185K20-21852026-06-10
00841668146569BarronK20-2187K20-21872026-06-10
00841668146576BarronK20-2195K20-21952026-06-10
00841668146590BarronK20-2190K20-21902026-06-10
00841668146606BarronK20-2192K20-21922026-06-10
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841668114848Color Bar Schirmer Tear TestKATENA PRODUCTS, INC.KYD2023-07-06
14582495170145SMTubeECHO ELECTRICITY CO.,LTD.KYD2020-07-25
24582495170142SMTubeECHO ELECTRICITY CO.,LTD.KYD2020-07-25
05060179470726Haag Streit UKHAAG-STREIT UK LIMITEDKYD2016-07-22