AccessGUDID - DEVICE: PHACO SET PLUS 21G,BICONICAL,15° (04049539102492)

GUDID

Device Identifier (DI) Information

Brand Name: PHACO SET PLUS 21G,BICONICAL,15°
Version or Model: 303060-1023-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec AG

Primary DI Number: 04049539102492
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342228620 *Terms of Use

Device Description: This single use device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human cataract surgery. (consists of TEST CHAMBER, PHACO TIP and SILICONE SLEEVE).

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?
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	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: 95268840-d67f-49fe-884a-4a1d922d5262
Public Version Date: January 31, 2024
Public Version Number: 2
DI Record Publish Date: April 25, 2022