AccessGUDID - DEVICE: 2.5 mm Triple step angled flared phaco needle. (limited reusable 20x) (08717872018652)

GUDID

Device Identifier (DI) Information

Brand Name: 2.5 mm Triple step angled flared phaco needle. (limited reusable 20x)
Version or Model: 3005.AF25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3005.AF25
Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Primary DI Number: 08717872018652
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 407522184 *Terms of Use

Device Description: No description.

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?
34900	Phacoemulsification system handpiece	A holder for a dedicated detachable tip that together become a unit that delivers energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). This device will be activated by the surgeon using a foot control and may provide or facilitate the irrigation/suction systems needed for the removal of debris. The handpiece typically designed in the form of a pen or pencil. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQC	Unit, Phacofragmentation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190875	000

Device Exempt from Premarket Submission: No 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: dc1ef691-a78d-45d7-81f5-c3b4a878cf76
Public Version Date: March 19, 2020
Public Version Number: 6
DI Record Publish Date: September 23, 2016