AccessGUDID - DEVICE: Surgical Scissor S/B 14.5 cm (G20214016941416)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Scissor S/B 14.5 cm
Version or Model: 140169414
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14-01694-14
Company Name: CONCISE ENTERPRISES

Primary DI Number: G20214016941416
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645816062 *Terms of Use

Device Description: The Surgical Scissor S/B 14.5 cm is a surgical instrument used during surgical procedures to cut or dissect tissues, sutures, or other materials. The S/B in the name stands for straight and blunt, referring to the shape of the tips of the scissor blades. The scissor typically has a length of 14.5 cm (5.7 inches) and features a straight design with blunt tips. The blades of the scissor are made of stainless steel and are sharpened to provide a precise cutting edge. The tips of the blades are smooth and flat, without any teeth or serrations, to prevent damage to delicate tissues. The Surgical Scissor S/B 14.5 cm is designed for use in a variety of surgical procedures, including general surgery, orthopedics, and plastic surgery. The instrument is typically made of high-quality stainless steel for durability and ease of cleaning and sterilization. Surgical scissors come in various shapes and sizes, and the Surgical Scissor S/B 14.5 cm is a specific model designed for use in a variety of surgical procedures. The instrument is typically used in conjunction with other surgical instruments, such as forceps or retractors, to perform precise surgical procedures.

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?
38727	General-purpose surgical scissors, reusable	A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.	Active	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: 89f3f53a-e128-489a-9a42-a28cffea6b44
Public Version Date: April 13, 2023
Public Version Number: 1
DI Record Publish Date: April 05, 2023