AccessGUDID - DEVICE: Enucleation and Utility Scissors (08175700148023)

GUDID

Device Identifier (DI) Information

Brand Name: Enucleation and Utility Scissors
Version or Model: AS12-072
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS12-072
Company Name: AURORA SURGICAL, LLC

Primary DI Number: 08175700148023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968368832 *Terms of Use

Device Description: Utility Scissors, One Pointed and One Blunt Tip, 5 3/4" (14.5cm) Long, Straight

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?
13487	Enucleation scissors, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut tissue during surgery involving enucleation of the eye and/or its related structures (i.e., the removal of the eyeball to, e.g., remove a malignant tumour or to relieve intolerable pain in a blind eye). 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 high-grade stainless steel 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 [?]
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: 39871a61-8f2f-4df8-afef-b1b08d2c832e
Public Version Date: August 01, 2023
Public Version Number: 1
DI Record Publish Date: July 24, 2023