AccessGUDID - DEVICE: GYRUS ACMI (00821925010185)

GUDID

Device Identifier (DI) Information

Brand Name: GYRUS ACMI
Version or Model: 5720009
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gyrus ACMI, LLC

Primary DI Number: 00821925010185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007198742 *Terms of Use

Device Description: Surlok Stone Grasping Forceps Nonretracting 4.5 FR (1.5 mm) X 70 cm Basket Width: 16 mm # of Wires: 3

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
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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 127d1fdd-0522-4c67-ae0c-5037c9bf3411
Public Version Date: September 02, 2024
Public Version Number: 4
DI Record Publish Date: October 03, 2016