AccessGUDID - DEVICE: Ahmed ClearPath ST (00892064002096)

GUDID

Device Identifier (DI) Information

Brand Name: Ahmed ClearPath ST
Version or Model: ST350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-0610
Company Name: NEW WORLD MEDICAL, INCORPORATED

Primary DI Number: 00892064002096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622768711 *Terms of Use

Device Description: Glaucoma shunt

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?
61127	Glaucoma shunt	A non-bioabsorbable, implantable ocular device intended to create an artificial drainage channel for diversion of aqueous humour from the anterior chamber of the eye to reduce intraocular pressure (IOP) as an alternative to, or after failed, trabeculectomy, for the management of uncontrolled glaucoma. It consists of a tube which is introduced into the aqueous body (typically via limbal entry) and a distal episcleral plate intended to support a reservoir of aqueous humour; the shunt does not contain a valve.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KYF	Implant, Eye Valve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Area/Surface Area: 350 Square millimeter

Device Record Status

Public Device Record Key: 6d81bc06-c27e-46fd-802c-75eb40c1c32c
Public Version Date: December 26, 2024
Public Version Number: 1
DI Record Publish Date: December 18, 2024