"PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"" Delivery System"
- Primary DI
- 20705032039472
- Brand
- "PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"" Delivery System"
- Company
- Cordis US Corp.
- Model
- PG2950BPS
- Catalog number
- PG2950BPS
- Published
- 2015-08-28
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- true
Product 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 |
|---|---|
| K033394 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20705032039472 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20705032039472 | 20705032039472 |
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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Do not use open or damaged packages |
| Special Storage Condition, Specify | 0 | 0 | Store in a cool, dark, dry place. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 118274128
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
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