AccessGUDID - DEVICE: Dissecting Forceps Fine 15cm (G2021502806150)

GUDID

Device Identifier (DI) Information

Brand Name: Dissecting Forceps Fine 15cm
Version or Model: 150280615
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15-02806-15
Company Name: CONCISE ENTERPRISES

Primary DI Number: G2021502806150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645816062 *Terms of Use

Device Description: Dissecting forceps are a type of surgical instrument commonly used in medical procedures to manipulate, grasp, and dissect tissue. The "Fine" 15cm dissecting forceps are a specific type of dissecting forceps with the following features: Size: 15cm (6 inches) in length Tips: Fine and pointed, designed for delicate dissection and grasping of small tissue structures Jaws: Straight and smooth, with serrations or ridges to provide a secure grip on tissue Handle: Finger rings or handles at the proximal end of the forceps, which the surgeon or medical professional uses to manipulate the instrument. The "Fine" 15cm dissecting forceps may be used in a wide range of surgical procedures, including but not limited to microsurgery, ophthalmic surgery, and other delicate surgical applications where precision and fine control are necessary. It is important to note that surgical instruments such as dissecting forceps must be cleaned, sterilized, and maintained according to standard protocols to ensure patient safety and prevent the spread of infections.

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?
62479	Surgical soft-tissue manipulation forceps, tweezers-like, single-use	A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a single-use 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: 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: 13212029-481d-4ae2-8f7c-733315b1bf6e
Public Version Date: April 17, 2023
Public Version Number: 1
DI Record Publish Date: April 08, 2023