AccessGUDID - DEVICE: Eye-Cept Rewetting Drops (00364108411121)

GUDID

Device Identifier (DI) Information

Brand Name: Eye-Cept Rewetting Drops
Version or Model: 411
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OPTICS LABORATORY, INC.

Primary DI Number: 00364108411121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018503552 *Terms of Use

Device Description: Eye-Cept rewetting drops, 20 x 0.5ml

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):	No
Over the Counter (OTC):	Yes
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?
35062	Eye dropper, single-use	A pipette-like device intended to be used for aspirating a small volume of liquid so that it can be dispensed in single drops onto the external surface of the eye. It is typically designed as a hollow tube, with an aspiration bulb attached to the proximal end and a narrowed opening at the distal end. It is usually made of glass or plastic with a rubber teat. It may contain a medication. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPN	Accessories, Soft Lens Products

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041008	000

Device Exempt from Premarket Submission: No 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: 6528b6d9-bc85-49c8-9f0f-c57c7ee895bb
Public Version Date: April 21, 2021
Public Version Number: 4
DI Record Publish Date: June 07, 2016

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: No Unit of Use DI Numbers Found 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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