AccessGUDID - DEVICE: Talon (00816765011300)

GUDID

Device Identifier (DI) Information

Brand Name: Talon
Version or Model: 00711175
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711175
Company Name: US Endoscopy

Primary DI Number: 00816765011300
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The Talon grasping device is used to retrieve of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.

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:	Yes
Prescription Use (Rx):	Yes
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
FGO	DISLODGER, STONE, FLEXIBLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 160 Centimeter
Outer Diameter: 2.5 Millimeter

Device Record Status

Public Device Record Key: 67d2bf96-304b-4cd8-8537-26982097e53f
Public Version Date: March 17, 2020
Public Version Number: 6
DI Record Publish Date: September 17, 2016