DEVICE: AccuPak, Accurus, Alcon (00380657502479)

Device Identifier (DI) Information

AccuPak, Accurus, Alcon
8065750247
In Commercial Distribution

Alcon Laboratories, Inc.
00380657502479
GS1

1
008018525 *Terms of Use
AccuPak Convertible Irrigation/Aspiration Tubing Set
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ultrasonic surgical system tubing set A sterile collection of dual-lumen tubing and connectors that are used in an ultrasonic surgical system to transport irrigation fluid through one lumen to the surgical site, and remove the aspirate through the other for collection in a suction bottle/canister. The tubing connects to the system's generator at one end and will typically be fitted with safety connectors; it is used only with systems that include irrigation/aspiration. This is a single-use device.
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

576b97d9-b42b-49bd-9ac5-ec102fecd81d
March 29, 2018
2
September 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10380657502476 6 00380657502479 In Commercial Distribution Box
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)862-5266
web.masterus@alcon.com
CLOSE