AccessGUDID - DEVICE: Deflux (00850004725009)

GUDID

Device Identifier (DI) Information

Brand Name: Deflux
Version or Model: Gel 1.0 mL Syringe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 011504
Company Name: PALETTE LIFE SCIENCES, INC.

Primary DI Number: 00850004725009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116951700 *Terms of Use

Device Description: Deflux injectable gel

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?
60700	Urinary tract reconstructive material, microbe-derived	A sterile, bioabsorbable material intended for submucosal injection in the urinary tract (urethra, urinary bladder, and/or distal ureter) to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of stress urinary incontinence (SUI) and/or vesicoureteral reflux (VUR); it does not include a local anaesthetic agent. It is in the form of a gel of biosynthesized dextranomer microspheres and hyaluronic acid (HA) derived from bacteria. The material is typically preloaded in a disposable syringe.	Active	true

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
Special Storage Condition, Specify: Protect from freezing and sunlight
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: ec9f441b-b08f-4712-bb2e-9f2ed18b1d7d
Public Version Date: March 02, 2023
Public Version Number: 2
DI Record Publish Date: February 01, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-844-822-7744
Email: support@palettelifesciences.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES