AccessGUDID - DEVICE: MICROKERATOME Disposable Tubing (04050555000839)

GUDID

Device Identifier (DI) Information

Brand Name: MICROKERATOME Disposable Tubing
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5070063
Company Name: Technolas Perfect Vision GmbH

Primary DI Number: 04050555000839
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341325716 *Terms of Use

Device Description: Provides a connection between the microkeratome head and the vacuum (or suction) pump. The function of the tubing is to provide a conduit for suction to the eye during lamellar surgery.

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):	No
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?
32765	Keratome, line-powered	A mains electricity (AC-powered) ophthalmic surgical instrument intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. This device will typically have a special blade mounted to it for the cutting process.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNO	Keratome, Ac-Powered

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
Storage Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65285606-680c-4f1b-a474-acec5b418029
Public Version Date: December 03, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016