AccessGUDID - DEVICE: Latex-free Rubber Suction Cups (100 units) (20697660004611)

GUDID

Device Identifier (DI) Information

Brand Name: Latex-free Rubber Suction Cups (100 units)
Version or Model: 5360LF-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Oculo-Plastik Inc

Primary DI Number: 20697660004611
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 257382580 *Terms of Use

Device Description: Latex-free Rubber Suction Cups (100 units)

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?
63962	Corneal shield applicator	A hand-held manual device designed to place a shield on a patient’s cornea for protection during a medical procedure (e.g., periorbital surgery, dermatological laser treatment). It is typically in the form of a soft bulb or cup that when squeezed creates gentle suction against the shield, enabling the user to lift the shield and then gently position it on the patient’s cornea. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYE	Inserter/Remover Contact Lens

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: No
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: 8320ff07-19b8-4161-ac52-64f306608358
Public Version Date: November 18, 2019
Public Version Number: 1
DI Record Publish Date: November 08, 2019