AccessGUDID - DEVICE: Key Surgical Foreign Body Retrievers (00849771039945)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Foreign Body Retrievers
Version or Model: EN10135A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771039945
Issuing Agency: GS1
Commercial Distribution End Date: February 25, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Grasping Forceps, 3-Pod Type, 2.3mm Diam, 2300mm L

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?
33199	Flexible endoscopic tissue manipulation forceps, single-use	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDJ	Clamp, Surgical, General & Plastic Surgery

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
Outer Diameter: 2.3 Millimeter
Length: 2300 Millimeter

Device Record Status

Public Device Record Key: 842bb98e-bf9d-4f7f-9038-1475775041b0
Public Version Date: February 25, 2022
Public Version Number: 5
DI Record Publish Date: August 05, 2020