AccessGUDID - DEVICE: CASTROVIEJO CORNEOSCLERAL SCISSORS (00192896099531)

GUDID

Device Identifier (DI) Information

Brand Name: CASTROVIEJO CORNEOSCLERAL SCISSORS
Version or Model: 13-1320F
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13-1320F
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896099531
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: CASTROVIEJO CORNEOSCLERAL SCISSORS MEDIUM RIGHT ANGLED BLADES FENESTRATED HANDLE

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?
13486	Corneal scissors, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut corneal tissue (e.g., during cataract extraction surgery, corneal transplant surgery). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. This is a reusable device.	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 [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 4.25 Inch
Device Size Text, specify: 11 Millimeter Blades

Device Record Status

Public Device Record Key: 6053a460-ebad-48b6-9357-a36cced4226e
Public Version Date: October 18, 2023
Public Version Number: 6
DI Record Publish Date: September 19, 2018