FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Posi-Stick Introducer Set
DI: H862PS2000
·
Model: PS2-00
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Posi-Stick Introducer Set
- Primary DI
- H862PS2000
- Version / Model
- PS2-00
- Catalog Number
- PS2-00
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-29
- Public Version
- 3
- Public Version Date
- 2019-09-12
- Public Version Status
- Update
- Public Device Record Key
- 83255937-6a4d-4442-bcfb-717ade8b4f67
- Distribution End Date
- 2019-09-11
Device Description
Posi-Stick Introducer Set w/PT Marker
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
- 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 |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46448 | Fascial tissue dilator, single-use | A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H862PS2002 | HIBCC | Shipper | 1 | Not in Commercial Distribution | 2019-09-11 |
| Package | H862PS2001 | HIBCC | Dispenser | 10 | Not in Commercial Distribution | 2019-09-11 |
| Primary | H862PS2000 | HIBCC |
Customer Contacts
- Phone
- 1-800-538-7374
- [email protected]