AccessGUDID - DEVICE: Medetz Surgical Instruments (G22314020090)

GUDID

Device Identifier (DI) Information

Brand Name: Medetz Surgical Instruments
Version or Model: 14-0200-9
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medetz Surgical Instruments LLC

Primary DI Number: G22314020090
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 876570990 *Terms of Use

Device Description: Camellin Style LASEK 9.0mm Alcohol Well, Flat Handle, Stainless Steel

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:	No
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?
63523	LASEK alcohol well, reusable	A hand-held, manual, ophthalmic surgical device designed to hold a small reservoir of alcohol solution at the surface of the cornea to soften the corneal epithelium for subsequent epithelial flap creation during laser-assisted epithelial keratomileusis (LASEK) surgery. It may additionally be designed to hold/assist placement of the dedicated trephine (cylindrical cutting blade) at the surface of the eye during flap creation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNB	Spoon, Ophthalmic

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: fd1d4dae-583c-4a69-8a88-0bbd799db2ae
Public Version Date: June 12, 2025
Public Version Number: 1
DI Record Publish Date: June 04, 2025