AccessGUDID - DEVICE: SINGLE USE ASPIRATION NEEDLE (04953170402012)

GUDID

Device Identifier (DI) Information

Brand Name: SINGLE USE ASPIRATION NEEDLE
Version or Model: NA-U401SX-4025N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170402012
Issuing Agency: GS1
Commercial Distribution End Date: February 21, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: Single Use Aspiration Needle NA-U401SX-4025N

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?
46678	Flexible endoscopic biopsy handpiece/needle	A sterile flexible device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTI	Bronchoscope accessory

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190239	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: 7446e26b-2cde-415e-b5fa-d4e36bb0acc9
Public Version Date: April 16, 2025
Public Version Number: 5
DI Record Publish Date: February 10, 2020