AccessGUDID - DEVICE: ML7030 (Minus 10) (00850724001032)

GUDID

Device Identifier (DI) Information

Brand Name: ML7030 (Minus 10)
Version or Model: ML7030 (-10)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ML7030 (-10)
Company Name: MED LOGICS INC

Primary DI Number: 00850724001032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075390489 *Terms of Use

Device Description: Sterile disposable microkeratome blade, for use on the Nidek® MK-2000 Keratome System, Sample

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 [?]
K010872	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 7ee0b4bf-9590-418c-9a31-788b4e4c25e2
Public Version Date: August 18, 2020
Public Version Number: 2
DI Record Publish Date: July 21, 2020