Identity
- Trade Name
- Deflux FDA UDI
- Generic Name
- Urinary tract reconstructive material, microbe-derived FDA UDI
- Device Name
- Deflux injectable gel FDA UDI
- Model / Reference
- Gel 1.0 mL Syringe FDA UDI
- Description
- Deflux injectable gel FDA UDI
Identifiers
- Catalog Number
- 011504 FDA UDI
- Primary DI / UDI-DI
- 00850004725009 FDA UDI
- PMA Number
- P000029 FDA UDI
- FDA Product Code
- LNM FDA UDI
- GMDN Term
- Urinary tract reconstructive material, microbe-derived FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Urinary tract reconstructive material, microbe-derived
Deflux by Palette Life Sciences — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary tract reconstructive material, microbe-derived.
- Deflux® — SALIX PHARMACEUTICALS, LTD. · Class III
Cleared under the same submission
P000029 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Palette Life Sciences
Sources (1)
- FDA UDI ec9f441b-b08f-4712-bb2e-9f2ed18b1d7d 38 fields · synced Jun 1, 2026