AccessGUDID - DEVICE: Curved Down Forceps, Bayonet Handle, .5mm tips, 210mm (00856312006366)

GUDID

Device Identifier (DI) Information

Brand Name: Curved Down Forceps, Bayonet Handle, .5mm tips, 210mm
Version or Model: N3203
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KATALYST SURGICAL LLC

Primary DI Number: 00856312006366
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007883297 *Terms of Use

Device Description: Each, Dissection Forceps, 210mm

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?
15800	Dissection forceps	A surgical instrument used to facilitate grasping, manipulation, compression or joining of tissue during dissection and/or autopsy. It typically has two main designs: 1) a self-retaining, scissors-like design with ring handles with the working end having a variety of blade designs, e.g., straight, angled, or curved with parallel grooves or serrations to provide grip; and 2) tweezers-like design (may be a micro/fine instrument) with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes and may have carbide inserts at the working end. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HTD	Forceps

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: 194ba9bf-5422-498c-a5ca-887d46988394
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 29, 2016