Barrigel Injectable Gel
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Barrigel Injectable Gel EUDAMED
- Device Name
- BARRIGEL SYRINGE (3ML) EUDAMED
- Model / Reference
- 011507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850004725061 EUDAMED
- Basic UDI-DI
- B-00850004725061 EUDAMED
- 510(k) Number
- K220641 FDA 510(k)
- FDA Product Code
- OVB FDA 510(k)
- EMDN Code
- T030499 RADIOTHERAPY PROTECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5725 FDA 510(k)
- Regulation Number
- 892.5725 FDA 510(k)
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Barrigel Injectable Gel is a Hydrogel Spacer, a radiopaque, injectable substance designed to create space between anatomical structures. It is formulated to provide temporary separation, particularly in radiology procedures where maintaining tissue separation is critical, such as in breast augmentation or reconstruction.
This device is supplied as a sterile, single-use injectable gel intended for use in radiology settings. It is classified as a Class II medical device under FDA regulations and adheres to the Medical Device Directive (MDD) in the EU. The gel is packaged in sterile, pre-filled syringes and must be stored under controlled conditions as specified by the manufacturer to ensure sterility and efficacy.
Frequently asked questions
What is the Barrigel Injectable Gel primarily used for in clinical settings?
The Barrigel Injectable Gel is designed to create and maintain space between anatomical structures during radiology procedures. It is particularly useful in scenarios like breast augmentation or reconstruction where temporary tissue separation is critical, ensuring clarity and precision in imaging or surgical planning.
How is the Barrigel Injectable Gel supplied, and is it reusable?
The Barrigel Injectable Gel is supplied as a sterile, single-use product in pre-filled syringes. This design ensures sterility and prevents cross-contamination, making it unsuitable for reuse. Each syringe is intended for one-time use only.
What storage conditions must be followed to maintain the gel’s sterility and effectiveness?
The manufacturer specifies that the Barrigel Injectable Gel must be stored under controlled conditions to preserve sterility and efficacy. While exact storage details are not provided, typical hydrogel spacers require protection from extreme temperatures, moisture, and physical damage. Always refer to the packaging instructions for precise storage guidelines.
Is the Barrigel Injectable Gel radiopaque, and if so, why does that matter?
Yes, the Barrigel Injectable Gel is radiopaque, meaning it is visible under X-ray imaging. This feature is important in radiology procedures because it allows clinicians to confirm the placement and integrity of the gel spacer during imaging, ensuring it performs its intended function of separating tissues accurately.
How do I know which regulatory pathway this device follows, and what does that mean for its use?
The Barrigel Injectable Gel follows the FDA’s 510(k) clearance process under the Traditional pathway, with a decision of Substantially Equivalent (SE) to a predicate device. This means it has been reviewed and deemed comparable to an existing device in terms of safety and effectiveness for its intended use in radiology. Additionally, it complies with the Medical Device Directive (MDD) in the EU, ensuring it meets European regulatory standards for Class II devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220641 | Class II | Active |
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Manufacturer
- Manufacturer
- Palette Life Sciences
Sources (2)
- FDA 510(k) K220641 24 fields · synced Sep 18, 2026
- EUDAMED bf668dde-d853-4b04-ac6a-1121e4e7463d 61 fields · synced Jul 9, 2026