AccessGUDID - DEVICE: KAMRA inlay (00813359020052)

GUDID

Device Identifier (DI) Information

Brand Name: KAMRA inlay
Version or Model: 76225-10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Bausch & Lomb Incorporated

Primary DI Number: 00813359020052
Issuing Agency: GS1
Commercial Distribution End Date: February 03, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 196603781 *Terms of Use

Device Description: Carton Assy, US, KAMRA Pod, Dispenser Carton Assembly

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?
47959	Corneal inlay, aperture reducing	A sterile implantable device inserted into the natural cornea to treat presbyopia [age-related hyperopia (far sightedness)] based on aperture reduction. It is typically made of plastic material and is shaped as a thin annulus (disc) formed to fit the curvature of the cornea; it includes a central opening that restricts the optical aperture of the eye to increase depth of field. It is intended for long-term implantation and is surgically inserted in an intrastromal pocket or flap made by a keratome or an appropriate laser.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LQE	Implant, Corneal, Refractive

FDA Premarket Submission

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

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: 42e6d9cd-1ccc-402c-86c9-a57dae89c9d2
Public Version Date: June 21, 2024
Public Version Number: 4
DI Record Publish Date: January 13, 2017