AccessGUDID - DEVICE: GemcisionTM Keratome, Super Sharp, 3.0mm Width/Box of 5 (00840096207224)

GUDID

Device Identifier (DI) Information

Brand Name: GemcisionTM Keratome, Super Sharp, 3.0mm Width/Box of 5
Version or Model: 7920-K30b
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KATALYST SURGICAL LLC

Primary DI Number: 00840096207224
Issuing Agency: GS1
Commercial Distribution End Date: December 08, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 007883297 *Terms of Use

Device Description: GemcisionTM Keratome, Super Sharp, 3.0mm Width/Box of 5

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?
32764	Ophthalmic knife, reusable	A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNN	Knife, 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: 7f627bf1-51dc-4562-8d29-92607e4de71c
Public Version Date: December 09, 2022
Public Version Number: 2
DI Record Publish Date: June 05, 2020