AccessGUDID - DEVICE: KXL System (00855574003083)

GUDID

Device Identifier (DI) Information

Brand Name: KXL System
Version or Model: 110-02724
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AVEDRO, INC.

Primary DI Number: 00855574003083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007274362 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
57950	Ophthalmic crosslinking ultraviolet phototherapy system	A mains electricity (AC-powered) mobile device assembly, with a rechargeable battery, designed to deliver a uniform and metered dose of ultraviolet A (UVA) light to the cornea to perform an ophthalmic crosslinking procedure (collagen fibres in the cornea are linked together to stiffen the cornea). It is normally used in a clinical office setting and typically consists of a wheeled central mount that supports the optic head containing the UV source, user control panel, software, and a rechargeable battery. It is typically used to treat corneal disorders such as keratoconus, post laser assisted in situ keratomileusis (LASIK) ectasia, and other post-LASIK disorders.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMF	Stand, Instrument, Ac-Powered, Ophthalmic

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: 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: 1db953ae-dc36-4c16-8cc8-8dd53616ca5a
Public Version Date: July 14, 2025
Public Version Number: 2
DI Record Publish Date: January 07, 2020

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 844-528-3376
Email: usaorders@avedro.com

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