AccessGUDID - DEVICE: Absorbent Kit (00813465012224)

GUDID

Device Identifier (DI) Information

Brand Name: Absorbent Kit
Version or Model: 9803
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9803
Company Name: HURRICANE MEDICAL INC

Primary DI Number: 00813465012224
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 093377724 *Terms of Use

Device Description: Each kit contains one 9101 Instrument Wipe, one 9802 Fluid Wick, one 9202 Corneal Light Shield, all used for fluid absorption during eye surgery.

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):	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?
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 [?]
K990671	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization
Ethylene Oxide

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: 5db47230-05c2-47ec-be5f-31bee32778b3
Public Version Date: April 10, 2020
Public Version Number: 5
DI Record Publish Date: February 16, 2017