AccessGUDID - DEVICE: Intacs Corneal Separator, CW, 0.9mm (00850048576001)

GUDID

Device Identifier (DI) Information

Brand Name: Intacs Corneal Separator, CW, 0.9mm
Version or Model: KV10730-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADDITION TECHNOLOGY, INC.

Primary DI Number: 00850048576001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118496814 *Terms of Use

Device Description: The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each Corneal Separator is inserted through the 0.9 mm entry incision to create either a CW or a CCW annular subsurface tunnel. The Corneal Separators are designed for use with the Vacuum Centering Guide (VCG). Each Corneal Separator is designed to slide easily into the VCG and to rotate smoothly through the stroma to precisely create the CW and CCW intrastromal tunnels within the cornea.

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):	No
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?
39610	General-purpose surgical spatula	A hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HND	Spatula, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea955f37-756e-47f9-a3dc-5b3648f3b258
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023