FDA UDI
In Commercial Distribution
🇺🇸 United States
TRUFILL
DI: 10886704029410
·
Model: 635-002
·
Medos International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TRUFILL
- Primary DI
- 10886704029410
- Version / Model
- 635-002
- Catalog Number
- 635002
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-20
- Public Version
- 5
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 47bfa502-5d77-40fc-ac03-3274a545aaf4
Device Description
TRUFILL DCS Syringe II
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 |
|---|---|---|---|---|
| HCG | DEVICE, NEUROVASCULAR EMBOLIZATION | Neurology | 882.5950 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43989 | Embolization implant syringe | A hollow barrel fitted with a threaded plunger and a pressure gauge, designed to place an embolic implant in the body. The device provides precise pressure control for the preparation (purging) and release of an implantable device after it has been surgically positioned at the target site using a delivery tube (e.g., an appropriate catheter). The plunger has a locking mechanism for added control, and the device comes equipped with a flexible, high-pressure extension tube. The pressure gauge will typically facilitate settings for purging, implant placement, and detachment (launch). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886704029410 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]