AccessGUDID - DEVICE: DMV Luma Serter Plus (00080875974248)

GUDID

Device Identifier (DI) Information

Brand Name: DMV Luma Serter Plus
Version or Model: 424
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 424
Company Name: DMV CORPORATION

Primary DI Number: 00080875974248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084436906 *Terms of Use

Device Description: 45 degree Inserter for large contact lenses to be used with a pen light. No suction

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
42810	Rigid contact lens inserter/remover	A device designed to insert and remove hard and semi-rigid contact lenses from the eye. It typically consists of a small, hand-held device that has a handle and a concave cup-like distal end; some devices include a vented handle that provides manually-adjustable suction for lens removal. The device is used to avoid hard and semi-rigid lens contamination and to facilitate lens removal and insertion typically by users with low dexterity, long nails, or rough fingers; it is also used by contact lens wearers in dirty environments. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYE	Inserter/Remover Contact Lens

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K830496	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: abd4a30c-0347-4654-917b-d0c3377cae94
Public Version Date: April 14, 2020
Public Version Number: 1
DI Record Publish Date: April 06, 2020