AccessGUDID - DEVICE: Inlay Inserter Chuck Handle (10850394006051)

GUDID

Device Identifier (DI) Information

Brand Name: Inlay Inserter Chuck Handle
Version or Model: 607-0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 607-0002
Company Name: REVISION OPTICS, INC.

Primary DI Number: 10850394006051
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015504442 *Terms of Use

Device Description: The Inlay Inserter Chuck Handle is used in conjunction with the Inlay Inserter to extend the length of the device for ease of use while delivering the Raindrop® Near Vision Inlay. The Inserter Handle has three components: the handle, the sleeve, and the chuck.

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:	No
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?
46724	Ophthalmic surgical instrument handle, manual	A hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQE	Implant, Corneal, Refractive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150034	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: In between use, store the packaged instrument in a dry and clean environment.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4bcb5c74-d5ed-4708-961d-df887e9282ba
Public Version Date: August 09, 2018
Public Version Number: 4
DI Record Publish Date: August 19, 2016