FDA UDI
In Commercial Distribution
🇺🇸 United States
Prometra Intrathecal Catheter
DI: 00810335020099
·
Model: 11823
·
Flowonix Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Prometra Intrathecal Catheter
- Primary DI
- 00810335020099
- Version / Model
- 11823
- Company Name
- Flowonix Medical, Inc.
- Labeler DUNS
- 013518517
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 20fedbcd-0b6e-4d03-9c57-f5c52843252e
Device Description
The Intrathecal Catheter is a sterile, single-piece, radiopaque, silicone catheter with a pre-inserted hydrophilic stiffening stylet that is used to assist in placing the catheter.
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
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47079 | Spinal infusion/drainage catheter | A sterile flexible tube intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column for infusion of materials (typically anaesthetic or analgesic substances during surgery, labour, or delivery), and/or drainage of cerebrospinal fluid (CSF) and/or other fluids. Devices intended to assist catheter insertion (e.g., Tuohy needle, suture) may be included. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810335020099 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080012 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose to direct sunlight