AccessGUDID - DEVICE: Nucleus Chopper - P. Koch (00813465011173)

GUDID

Device Identifier (DI) Information

Brand Name: Nucleus Chopper - P. Koch
Version or Model: 6810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6810
Company Name: HURRICANE MEDICAL INC

Primary DI Number: 00813465011173
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 093377724 *Terms of Use

Device Description: Used to break-up nucleus within capsular bag during phacoemulsification. Angled 6 mm from tip. Tip dimensions: diameter 0.30 mm, length 1.50 mm.

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?
11290	Open-surgery dissector	A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYB	Lens, Guide, Intraocular

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Radiation Sterilization
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 14 Millimeter
Outer Diameter: 0.30 Millimeter

Device Record Status

Public Device Record Key: f5a185ca-ba27-4ece-9b76-59186af8d9c0
Public Version Date: May 18, 2020
Public Version Number: 1
DI Record Publish Date: May 08, 2020