AccessGUDID - DEVICE: Ahmed™ ClearPath (00892064002348)

GUDID

Device Identifier (DI) Information

Brand Name: Ahmed™ ClearPath
Version or Model: 250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CP250
Company Name: NEW WORLD MEDICAL, INCORPORATED

Primary DI Number: 00892064002348
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?
67548	Glaucoma shunt, tubular, non-animal-derived	A non-bioabsorbable, implantable ocular tube, that does not include animal-derived materials, 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 is a metallic or synthetic polymer tube introduced into the anterior chamber (typically via limbal entry), that may include a distal episcleral plate intended to form a reservoir to facilitate drainage by the ocular tissues. Disposable devices associated with implantation may be packaged with the shunt.	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: 250 Square millimeter

Device Record Status

Public Device Record Key: 2c42358b-376b-4a1b-8887-b49481576722
Public Version Date: July 02, 2025
Public Version Number: 7
DI Record Publish Date: January 23, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(909)466-4304
Email: orders@newworldmedical.com

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