AccessGUDID - DEVICE: Foreign Body Retrieval Basket (00350770927695)

GUDID

Device Identifier (DI) Information

Brand Name: Foreign Body Retrieval Basket
Version or Model: 92769
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60728
Company Name: Avanos Medical, Inc.

Primary DI Number: 00350770927695
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: Foreign Body Retrieval Basket

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?
37141	Rigid endoscopic stone-retrieval forceps, reusable	A rigid manual device intended to be inserted through the working channel of a compatible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a very long instrument with one sliding and one stationary rod, or a sheath, whose distal ends are equipped with thin grasping claws in which the stone is seized and held for extraction. The claws are typically operated by scissors-like ring handles at the proximal end of the instrument. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDX	endoscopic cytology brush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941464	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b4a8e97-0729-4d9c-bd4c-0db6c49d0711
Public Version Date: June 22, 2023
Public Version Number: 2
DI Record Publish Date: September 10, 2019