AccessGUDID - DEVICE: Alcon (00380657517824)

GUDID

Device Identifier (DI) Information

Brand Name: Alcon
Version or Model: 8065751782
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380657517824
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: 25 Ga 6mm Valved Trocar Cannula Entry System, 1 ct

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":	Yes
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?
46840	Ophthalmic cannulation set, single-use	A collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQC	Unit, phacofragmentation
HQE	Instrument, vitreous aspiration and cutting, ac-powered

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
Length: 6 Millimeter
Device Size Text, specify: 25 Gauge

Device Record Status

Public Device Record Key: 5262b7af-69a0-4c17-9f5e-985fd27409cc
Public Version Date: October 29, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10380657517821	12	00380657517824		In Commercial Distribution	Box

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: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(800)862-5266
Email: web.masterus@alcon.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES