AccessGUDID - DEVICE: FleXNeedle (00856571007012)

GUDID

Device Identifier (DI) Information

Brand Name: FleXNeedle
Version or Model: 10005-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10005-1
Company Name: BRONCUS MEDICAL INC.

Primary DI Number: 00856571007012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078684808 *Terms of Use

Device Description: Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.

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?
47540	Soft-tissue biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	Bronchoscope (Flexible Or Rigid)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090853	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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: 2e8c1d55-d348-4ba5-9b08-51378eb3cd87
Public Version Date: February 22, 2019
Public Version Number: 4
DI Record Publish Date: May 12, 2017