AccessGUDID - DEVICE: DeRoyal (00749756142663)

GUDID

Device Identifier (DI) Information

Brand Name: DeRoyal
Version or Model: 34-507
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DEROYAL INDUSTRIES, INC.

Primary DI Number: 00749756142663
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096372255 *Terms of Use

Device Description: Eye Kit

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
13704	Ophthalmic sponge	A device made of absorbent material, e.g., gauze, cotton or cellulose, intended to be used to absorb excess fluid produced by the eye during microsurgical procedures and ophthalmic surgery such as cataract surgery and laser assisted in situ keratomileusis (LASIK) procedures. Some types can be used as an eyelid and lash guard and are typically shaped for use in conjunction with an eye speculum. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOZ	Sponge, 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: 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: 83e72ec2-5a32-4bc4-86ef-0391cb439b65
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50749756142668	10	00749756142663		In Commercial Distribution	Case
30749756142664	10	00749756142663		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(888)938-7828
Email: udisupport@deroyal.com

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