AccessGUDID - DEVICE: CONVERTORS (10885380142154)

GUDID

Device Identifier (DI) Information

Brand Name: CONVERTORS
Version or Model: 8441
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8441
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380142154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Eye Sheet

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:	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?
46697	Ophthalmic surgical drape	A protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMT	Drape, patient, 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: e154ed80-bdd1-46d5-bf0a-d858cd866c9f
Public Version Date: July 19, 2018
Public Version Number: 3
DI Record Publish Date: September 28, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50885380142152	40	10885380142154		In Commercial Distribution	CASE

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

[?]

No Customer Contact currently defined

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