AccessGUDID - DEVICE: Anatomical Dressing Forcep (G2021502788141)

GUDID

Device Identifier (DI) Information

Brand Name: Anatomical Dressing Forcep
Version or Model: 150278814
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15-02788-14
Company Name: CONCISE ENTERPRISES

Primary DI Number: G2021502788141
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645816062 *Terms of Use

Device Description: Anatomical dressing forceps are used in surgical procedures for grasping tissue. Often, the tips have "teeth" to securely hold a tissue. Typically anatomical forceps are designed to minimize damage to biological tissue. These forceps are used for delicate tissue handling and traction during a procedure.

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":	Yes
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 14.5 Centimeter

Device Record Status

Public Device Record Key: d5d2b5a8-540f-4184-9790-d32aa774c18c
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022