Barrigel 3016-1
GUDID 00850004725139
Barrigel convenience kit
PALETTE LIFE SCIENCES, INC.
Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer Radiotherapy protection spacer| Primary Device ID | 00850004725139 |
| NIH Device Record Key | e1e77575-a12a-4627-8cf8-207844f722ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Barrigel |
| Version Model Number | 3016-1 |
| Catalog Number | 3016-1 |
| 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 | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com | |
| Phone | 1-844-822-7744 |
| support@palettelifesciences.com |
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 |
Operating and Storage Conditions
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004725139 [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 | 2023-03-09 |
| Device Publish Date | 2023-03-01 |
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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