AccessGUDID - DEVICE: Deflux Metal Needle (00850004725023)

GUDID

Device Identifier (DI) Information

Brand Name: Deflux Metal Needle
Version or Model: 3.7 FR x 23 G (tip) x 350 mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DX1201
Company Name: PALETTE LIFE SCIENCES, INC.

Primary DI Number: 00850004725023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116951700 *Terms of Use

Device Description: Deflux metal needle

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?
45019	Submucosal injection needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomical structures with lumens. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNM	Agent, Bulking, Injectable For Gastro-Urology Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000029	084

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
Length: 350 Millimeter
Needle Gauge: 23 Gauge

Device Record Status

Public Device Record Key: 8c024a4e-a6eb-49b0-8d57-1ea470be0b8f
Public Version Date: March 02, 2023
Public Version Number: 2
DI Record Publish Date: February 11, 2019