FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Exodus
DI: H965104080
·
Model: 10408
·
NAVILYST MEDICAL, INC.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Exodus
- Primary DI
- H965104080
- Version / Model
- 10408
- Company Name
- NAVILYST MEDICAL, INC.
- Labeler DUNS
- 809699023
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 4
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- f18bed20-ad96-448a-8511-11cde77d6749
- Distribution End Date
- 2021-08-12
Device Description
10F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
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 |
|---|---|---|---|---|
| LJE | CATHETER, NEPHROSTOMY | Unknown | U | |
| GBO | CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4200 | 1 |
| FGE | CATHETER, BILIARY, DIAGNOSTIC | Gastroenterology, Urology | 876.5010 | 2 |
| GBX | CATHETER, IRRIGATION | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11305 | Closed-wound drain, non-bioabsorbable | A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H965104081 | HIBCC | BOX | 5 | Not in Commercial Distribution | 2021-08-12 |
| Primary | H965104080 | HIBCC |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 10 | French | |
| Length | 20 | Centimeter | |
| Outer Diameter | 3.4 | Millimeter |