AccessGUDID - DEVICE: Curity (10884521553590)

GUDID

Device Identifier (DI) Information

Brand Name: Curity
Version or Model: 2841
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2841
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521553590
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Eye Pad,Oval

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?
11661	Eye pad	A cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMP	PAD, EYE

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
Special Storage Condition, Specify: This side up;

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length, 2-5/8, IN; Width, 1-5/8, IN;

Device Record Status

Public Device Record Key: 9b4414a0-af46-44c2-be57-49e2c7c8e25d
Public Version Date: August 24, 2023
Public Version Number: 5
DI Record Publish Date: June 23, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884527020581	600	10884521553590	2023-08-24	Not in Commercial Distribution	CASE
10884527020584	50	10884521553590	2023-08-24	Not in Commercial Distribution	PACK_OR_INNER_PACK

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: No
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(508)261-8000
Email: covidien.udi@covidien.com

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