AccessGUDID - DEVICE: Ahmed™ Glaucoma Valve (00892064002133)

GUDID

Device Identifier (DI) Information

Brand Name: Ahmed™ Glaucoma Valve
Version or Model: S2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S2
Company Name: NEW WORLD MEDICAL, INCORPORATED

Primary DI Number: 00892064002133
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 622768711 *Terms of Use

Device Description: Polypropylene Glaucoma Drainage Device

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
42526	Eye valve	A sterile device designed to regulate the flow of fluid between the anterior chamber and the space around the conjunctiva of the eye by allowing flow when the pressure in the chamber is above a pre-set value (e.g., 8 to 10 mmHg). It is typically a very small (e.g., slit) valve implanted in the eye as a component of an eye stent, and typically used in patients with advanced glaucoma when, despite the use of medication, laser treatments, or a previous glaucoma filtration procedure (trabeculectomy), the addition of a drainage tube and valve (aqueous shunt) is recommended.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KYF	IMPLANT, EYE VALVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K925636	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 184 Square millimeter

Device Record Status

Public Device Record Key: 86ac5462-cff0-45be-a2b7-0d1d4153daac
Public Version Date: October 22, 2019
Public Version Number: 4
DI Record Publish Date: March 24, 2015