AccessGUDID - DEVICE: PHACOFIT (05050474520554)

GUDID

Device Identifier (DI) Information

Brand Name: PHACOFIT
Version or Model: OM05510114
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OM05510114
Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.

Primary DI Number: 05050474520554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103021940 *Terms of Use

Device Description: Inter-tip flush (5/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:	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?
45149	Ophthalmic surgical procedure kit, non-medicated, reusable	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	Cannula, 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: 906b5689-240a-41d6-b6b3-280ab94f3fbc
Public Version Date: July 29, 2024
Public Version Number: 4
DI Record Publish Date: November 16, 2018