FDA UDI
In Commercial Distribution
🇺🇸 United States
Barrigel
DI: 00850004725108
·
Model: 011508
·
PALETTE LIFE SCIENCES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Barrigel
- Primary DI
- 00850004725108
- Version / Model
- 011508
- Catalog Number
- 011508
- Company Name
- PALETTE LIFE SCIENCES, INC.
- Labeler DUNS
- 116951700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 2
- Public Version Date
- 2023-03-02
- Public Version Status
- Update
- Public Device Record Key
- eb97d421-ff17-4f7d-b3ae-2c3b5288bd21
Device Description
Barrigel injectable gel
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OVB | Hydrogel Spacer | Radiology | 892.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60424 | Radiotherapy protection spacer | A sterile, bioabsorbable material (e.g., liquid or gel) intended to be injected between the prostate and the rectum prior to radiotherapy of the prostate, to increase the distance between the prostate and the anterior rectal wall, thereby reducing exposure of the rectum to radiation. It is typically comprised of hyaluronic acid (HA) and may be available in a prefilled syringe. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850004725108 | GS1 |
Customer Contacts
- Phone
- 1-844-822-7744
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220641 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from freezing and sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius