AccessGUDID - DEVICE: NA (10810003221091)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MK-100100+10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MK-100100+10
Company Name: MICROSPECIALITIES, INC.

Primary DI Number: 10810003221091
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013469890 *Terms of Use

Device Description: MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, plus 10. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

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?
44722	Keratome blade, single-use	A surgical cutting device with a very sharp edge that is designed to be mounted into a keratome and is used to shave tissue from sections of the cornea. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNO	Keratome, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020482	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
Angle: +10 degree

Device Record Status

Public Device Record Key: 7e858170-b873-4c05-9194-d9b223e1ee8a
Public Version Date: April 01, 2024
Public Version Number: 3
DI Record Publish Date: February 13, 2019