AccessGUDID - DEVICE: Bard® Platinum Class™ Non-Retracting Grasping Forceps (00801741076558)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® Platinum Class™ Non-Retracting Grasping Forceps
Version or Model: 039690
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 039690
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741076558
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard® Platinum Class™ Non-Retracting Grasping Forceps

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):	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?
46685	Flexible endoscopic stone-retrieval forceps, single-use	A flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a flexible metal coil or plastic tube whose distal end is equipped with a pair of thin grasping claws in which the stone is seized and held for extraction. The claws are operated by a control handle at the proximal end of the instrument. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFL	DISLODGER, STONE, BASKET, URETERAL, METAL

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: 11 Millimeter
Length: 90 Centimeter

Device Record Status

Public Device Record Key: 99dfb261-80c7-4a6b-ad42-9ac01b9e3811
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 23, 2016