AccessGUDID - DEVICE: Oertli® (07630003909685)

GUDID

Device Identifier (DI) Information

Brand Name: Oertli®
Version or Model: VV621010A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Oertli-Instrumente AG

Primary DI Number: 07630003909685
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481505238 *Terms of Use

Device Description: I/A TUBING SYSTEM FOR FAROS/; CR3/SWISSTECH, INCL. INFUSION; SET, DRAINAGE BAG, PE-BAG

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:	Yes
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?
45071	Phacoemulsification system	An assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric) through a dedicated handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification (a procedure for the liquefaction and removal of the opaque lens nucleus in cataract surgery). The system will typically consist of a mains electricity (AC-powered) generator providing the energy, an irrigation and suction system for the removal of the debris, handpieces and cables, the tips/needles/electrodes, and a foot control.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQC	Unit, Phacofragmentation

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f673b2c8-928f-43c4-b959-7ef27be72b90
Public Version Date: December 13, 2021
Public Version Number: 4
DI Record Publish Date: September 20, 2016