AccessGUDID - DEVICE: Eyetec (05056100707276)

GUDID

Device Identifier (DI) Information

Brand Name: Eyetec
Version or Model: 1-423
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NETWORK MEDICAL PRODUCTS LIMITED

Primary DI Number: 05056100707276
Issuing Agency: GS1
Commercial Distribution End Date: January 18, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 458670304 *Terms of Use

Device Description: 1-423 Corneal Light Shield 10.0 mm 1 Piece per Pack Non-sterile

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):	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 [?]
K130117	000

Device Exempt from Premarket Submission: No 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: 5876ff99-63f2-4157-a25f-d0e08dffadc0
Public Version Date: February 22, 2021
Public Version Number: 3
DI Record Publish Date: February 25, 2020