AccessGUDID - DEVICE: IRIS CLASSIC SCISSORS (00192896073234)

GUDID

Device Identifier (DI) Information

Brand Name: IRIS CLASSIC SCISSORS
Version or Model: 13-7533
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13-7533
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896073234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: IRIS CLASSIC SCISSORS CURVED BLADE POWER CUT GOLD

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?
13488	Intraocular scissors, conventional-hinge, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or spring handles, and is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNF	SCISSORS, 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
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 4.125 Inch

Device Record Status

Public Device Record Key: 1247a9e2-4388-46ef-8f06-b4d44e2b2702
Public Version Date: October 22, 2018
Public Version Number: 1
DI Record Publish Date: September 20, 2018