AccessGUDID - DEVICE: Barrigel Applicator Needle (00850004725115)

GUDID

Device Identifier (DI) Information

Brand Name: Barrigel Applicator Needle
Version or Model: 3009-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3009-2
Company Name: PALETTE LIFE SCIENCES, INC.

Primary DI Number: 00850004725115
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116951700 *Terms of Use

Device Description: Barrigel applicator 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
OVB	Hydrogel Spacer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220641	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
Needle Gauge: 18 Gauge
Length: 20 Centimeter

Device Record Status

Public Device Record Key: 6f02f7dc-f420-4443-8df9-1553e919f883
Public Version Date: March 02, 2023
Public Version Number: 2
DI Record Publish Date: November 30, 2022