FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Palmaz Genesis
DI: 10705032057615
·
Model: PG595P
·
CORDIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Palmaz Genesis
- Primary DI
- 10705032057615
- Version / Model
- PG595P
- Catalog Number
- PG595P
- Company Name
- CORDIS CORPORATION
- Labeler DUNS
- 806136177
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-31
- Public Version
- 1
- Public Version Date
- 2024-08-08
- Public Version Status
- New
- Public Device Record Key
- 23657d41-12c8-4c93-97b3-e0eb084b6433
- Distribution End Date
- 2024-07-31
Device Description
STENT GENESIS 59MM PERIPHERAL
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 |
|---|---|---|---|---|
| FGE | Stents, drains and dilators for the biliary ducts | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43691 | Bare-metal biliary stent | A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705032057612 | GS1 | Box | 1 | Not in Commercial Distribution | 2024-07-31 |
| Primary | 10705032057615 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012087 | 000 |