AccessGUDID - DEVICE: Centurion (00653160010671)

GUDID

Device Identifier (DI) Information

Brand Name: Centurion
Version or Model: D100ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D100ST
Company Name: CENTURION MEDICAL PRODUCTS CORPORATION

Primary DI Number: 00653160010671
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017246562 *Terms of Use

Device Description: EYE DROPPER 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:	Yes
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?
35062	Eye dropper, single-use	A pipette-like device intended to be used for aspirating a small volume of liquid so that it can be dispensed in single drops onto the external surface of the eye. It is typically designed as a hollow tube, with an aspiration bulb attached to the proximal end and a narrowed opening at the distal end. It is usually made of glass or plastic with a rubber teat. It may contain a medication. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYW	CONTAINER, LIQUID MEDICATION, GRADUATED

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: 241f6c3a-a592-4810-abb8-625a41f3958c
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: January 01, 2022