AccessGUDID - DEVICE: Visian Toric ICL (Implantable Collamer Lens for Myopia) (00841542105101)

GUDID

Device Identifier (DI) Information

Brand Name: Visian Toric ICL (Implantable Collamer Lens for Myopia)
Version or Model: TMICL 12.1 (-13.0/1.5)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TMICL12.1
Company Name: STAAR SURGICAL COMPANY

Primary DI Number: 00841542105101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054751110 *Terms of Use

Device Description: Diopter: -13.0; Cylinder 1.5; Overall Diameter (Length): 12.1

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":	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?
47402	Umbilical cord clamp/cutter	A sterile, hand-held manual surgical instrument designed with a clamping and cutting mechanism to simultaneously clamp and sever the umbilical cord immediately after birth. It may be used on the maternal side of the umbilical cord and on the infant side, typically where the clamp remains until the cord stub falls off. It is typically made of plastic materials [e.g., polycarbonate (PC)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QCB	Phakic Toric Intraocular Lens

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030016	001

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
Storage Environment Temperature: less than 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ccd6e91c-8aa6-42ce-91f5-7b7d7e974227
Public Version Date: November 19, 2018
Public Version Number: 1
DI Record Publish Date: October 17, 2018