Identity
- Trade Name
- Barrigel FDA UDI
- Generic Name
- Radiotherapy protection spacer FDA UDI
- Device Name
- Barrigel injectable gel FDA UDI
- Model / Reference
- 011508 FDA UDI
- Description
- Barrigel injectable gel FDA UDI
Identifiers
- Catalog Number
- 011508 FDA UDI
- Primary DI / UDI-DI
- 00850004725108 FDA UDI
- 510(k) Number
- K220641 FDA UDI
- FDA Product Code
- OVB FDA UDI
- GMDN Term
- Radiotherapy protection spacer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5725 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 — 3 Milliliter FDA UDI
Category: Radiotherapy protection spacer
Barrigel by Palette Life Sciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiotherapy protection spacer.
- BioProtect Balloon Implant™ System — BIOPROTECT LTD · Class II
- SpaceOAR VUE™ System - 10mL — Boston Scientific · Class II
- SpaceOAR System — Boston Scientific · Class II
- Barrigel — PALETTE LIFE SCIENCES · Class II
Cleared under the same submission
K220641 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Palette Life Sciences
Sources (1)
- FDA UDI eb97d421-ff17-4f7d-b3ae-2c3b5288bd21 38 fields · synced May 30, 2026