AccessGUDID - DEVICE: HONAN BALLOON WITH PRESS VALVE (00841668112137)

GUDID

Device Identifier (DI) Information

Brand Name: HONAN BALLOON WITH PRESS VALVE
Version or Model: K 9-8410
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K 9-8410
Company Name: KATENA PRODUCTS, INC.

Primary DI Number: 00841668112137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085668598 *Terms of Use

Device Description: No description.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
15048	Intraocular pressure-reducing compression system	An assembly of manually-operated devices designed to reduce the intraocular pressure (IOP), i.e., internal pressure of the eye fluids, by applying a controlled, external, mechanical compression to the surface of the eye in preparation for ophthalmic surgery. It typically consists of a headband with an attached inflatable bellows that applies pressure, an air pump (e.g., a squeeze bulb), a pressure indicator (e.g., a manometer), and tubing. It is typically used prior to surgery to induce a temporary reduction of the IOP creating a condition known as "soft surgical eye", which helps in the prevention of haemorrhaging thus reducing the risk of a surgical procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCC	Applicator, Ocular Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K820526	000

Device Exempt from Premarket Submission: No 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: d46c77ef-4b85-420c-b040-acc45c83ab64
Public Version Date: February 21, 2025
Public Version Number: 4
DI Record Publish Date: September 22, 2016