FDA UDI
In Commercial Distribution
🇺🇸 United States
TRUFILL
DI: 10886704085317
·
Model: 632500NA
·
Cerenovus, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TRUFILL
- Primary DI
- 10886704085317
- Version / Model
- 632500NA
- Catalog Number
- 632500NA
- Company Name
- Cerenovus, Inc.
- Labeler DUNS
- 607846297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-23
- Public Version
- 2
- Public Version Date
- 2023-12-07
- Public Version Status
- Update
- Public Device Record Key
- d50bc440-2751-4d7d-a8cc-8544081eef69
Device Description
TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: 1 g n-BCA, self-piercing cap, 1 g Ta Powder, 10 mL Ethiodized Oil, (3) 1 mL and (3) 3 mL syringes, 30 mL beaker, 18 G blunt fill needle, (2) 21 G hypodermic needles, syringe labels
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 |
|---|---|---|---|---|
| KGG | tissue adhesive for use in embolization of brain arteriovenous malformations | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60939 | Neurovascular embolization plug | A non-bioabsorbable material (e.g., gel, liquid) intended to be implanted in a neurovascular blood vessel, to obstruct blood flow to treat a brain arteriovenous malformation (bAVM). It may be supplied as a liquid [e.g., ethylene vinyl alcohol (EVOH)], gel or powder intended to solidify or expand in situ to create a barrier to blood flow (embolus); it contains no pharmaceutical agents. It may be supplied with dedicated instruments for implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886704085317 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990040 | 031 |