AccessGUDID - DEVICE: Color Bar Schirmer Tear Test (00841668114841)

GUDID

Device Identifier (DI) Information

Brand Name: Color Bar Schirmer Tear Test
Version or Model: 0039
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0039
Company Name: KATENA PRODUCTS, INC.

Primary DI Number: 00841668114841
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 085668598 *Terms of Use

Device Description: (50 Pouches)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37863	Schirmer tear test strip	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYD	Strip, schirmer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90daa857-d613-4bb9-8981-b51774ba2a45
Public Version Date: July 14, 2023
Public Version Number: 1
DI Record Publish Date: July 06, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 10841668114848 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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