Barrigel
GUDID 00850004725108
Hydrogel (HA) Injectable Rectal Spacer
PALETTE LIFE SCIENCES, INC.
Radiotherapy protection spacer| Primary Device ID | 00850004725108 |
| NIH Device Record Key | eb97d421-ff17-4f7d-b3ae-2c3b5288bd21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Barrigel |
| Version Model Number | 011508 |
| Company DUNS | 116951700 |
| Company Name | PALETTE LIFE SCIENCES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004725108 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220641
FDA Product Code
| OVB | Hydrogel Spacer |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
On-Brand Devices [Barrigel]
| 00850004725108 | Hydrogel (HA) Injectable Rectal Spacer |
| 00850004725139 | Barrigel convenience kit |
Trademark Results [Barrigel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BARRIGEL 98135710 not registered Live/Pending |
GALDERMA HOLDING S.A. 2023-08-16 |
 BARRIGEL 97675590 not registered Live/Pending |
Galderma Holding SA 2022-11-14 |
 BARRIGEL 90581707 not registered Live/Pending |
Galderma Holding SA 2021-03-16 |
 BARRIGEL 88710466 not registered Live/Pending |
Nestlé Skin Health S.A. 2019-11-29 |
 BARRIGEL 87796309 not registered Dead/Abandoned |
Nestlé Skin Health S.A. 2018-02-13 |
 BARRIGEL 86781067 not registered Dead/Abandoned |
GALDERMA S.A. 2015-10-07 |
 BARRIGEL 86031059 not registered Dead/Abandoned |
GALDERMA S.A. 2013-08-07 |
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