Paramount Mini GPS
- Primary DI
- 00821684006382
- Brand
- Paramount Mini GPS
- Company
- Covidien LP
- Model
- PMB4-5-14-80
- Device description
- Balloon-Expandable Biliary Stent System
- Published
- 2015-10-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
covidien.comProduct Codes#
| Code | Name |
|---|---|
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K040653 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00821684006382 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00821684006382 | 00821684006382 | 821684006382 | 0821684006382 |
GMDN Terms#
| Term | Definition |
|---|---|
| Bare-metal biliary stent | A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 5 | French |
| Device Size Text, specify | 0 | |
| Length | 14 | Millimeter |
| Outer Diameter | 5 | Millimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Keep Dry |
| Special Storage Condition, Specify | 0 | 0 | Keep Dry;AVOID DIRECT SUNLIGHT |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(508)261-8000 | covidien.udi@covidien.com |
Regulatory Flags#
- DUNS number
- 968903703
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
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