AccessGUDID - DEVICE: Dressing Tissue Forcep (G20215039521415)

GUDID

Device Identifier (DI) Information

Brand Name: Dressing Tissue Forcep
Version or Model: 150295214
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15-02952-14
Company Name: CONCISE ENTERPRISES

Primary DI Number: G20215039521415
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645816062 *Terms of Use

Device Description: A dressing tissue forcep is a medical instrument typically used in surgical procedures. It is a handheld tool with two blades that are connected by a hinge, allowing the user to grasp and manipulate tissues or dressings with precision and control. The blades of a dressing tissue forcep are usually long and slender, with a pointed tip at the end of each blade for grasping tissue. The jaws of the forcep may be serrated or smooth, depending on the intended use. Dressing tissue forceps may be made of stainless steel or other materials that are easy to clean and sterilize. Some models may have a locking mechanism to hold tissues or dressings in place during procedures. Overall, dressing tissue forceps are versatile and essential tools for many surgical procedures, allowing medical professionals to perform delicate and precise maneuvers with ease.

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?
42500	Dressing/utility forceps, tweezers-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use.	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: c71a41b9-f0d4-46ef-b295-aa47cd85d01b
Public Version Date: April 14, 2023
Public Version Number: 1
DI Record Publish Date: April 06, 2023