AccessGUDID - DEVICE: ULTRAZYME (00827444000157)

GUDID

Device Identifier (DI) Information

Brand Name: ULTRAZYME
Version or Model: 90278
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90278
Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.

Primary DI Number: 00827444000157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103021940 *Terms of Use

Device Description: ULTRAZYME ENZYMATIC CLEANER 20 TABLETS

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):	No
Over the Counter (OTC):	Yes
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?
45599	Contact lens protein-removal solution	A formulation of proteolytic enzymes, that may or may not be dissolved in cleaning (and possibly disinfecting) contact lens solution, used to remove debris and protein deposits from reusable contact lenses, or to remove protein deposits only. The lenses are typically soaked for a period in the solution and then rinsed in fresh contact lens cleaning solution for the removal of any residual material. Protein build-up on contact lenses often occurs from tear secretion. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPN	Accessories, soft lens products

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: b608731e-7787-4212-9ff4-622d5b1b6faf
Public Version Date: February 26, 2020
Public Version Number: 4
DI Record Publish Date: September 21, 2016