AccessGUDID - DEVICE: 23ga Dex™ NanoTapered™ Awh Forceps (00817489021811)

GUDID

Device Identifier (DI) Information

Brand Name: 23ga Dex™ NanoTapered™ Awh Forceps
Version or Model: DVF4009-23
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KATALYST SURGICAL LLC

Primary DI Number: 00817489021811
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007883297 *Terms of Use

Device Description: Box of 5, 23ga Dex™ NanoTapered™ Awh Forceps

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:	Yes
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?
46710	Ophthalmic tissue forceps, single-use	A hand-held ophthalmic surgical instrument used to grasp, manipulate, compress, pull, or join eye and/or surrounding tissues during a surgical intervention. It is typically: 1) a one-piece instrument with a tweezers-like design having two conjoined blades with serrated tips at the working end; or 2) an instrument tip, with grasping blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HNR	Forceps, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 6f42d1f7-1e21-42d1-a0b3-d7731d3a3d3b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 10, 2016