FDA UDI
In Commercial Distribution
🇺🇸 United States
Prostar
DI: 08717648000621
·
Model: 12322-01
·
ABBOTT VASCULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Prostar
- Primary DI
- 08717648000621
- Version / Model
- 12322-01
- Catalog Number
- 12322-01
- Company Name
- ABBOTT VASCULAR INC.
- Labeler DUNS
- 964569052
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-21
- Public Version
- 4
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- f471e09b-c027-4b3a-b567-d87bed435ae5
Device Description
PROSTAR XL10F Percutaneous Vascular Surgical System
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 |
|---|---|---|---|---|
| MGB | DEVICE, HEMOSTASIS, VASCULAR | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52747 | Femoral vessel suture implantation set | A collection of hand-operated instruments designed for the percutaneous delivery of sutures to close a femoral artery or vein puncture site following a catheterization procedure; it is intended to reduce the time to haemostasis and ambulation for the patient. The collection typically consists of a sheath containing suture needles with sutures, needle guide, and a marker to control the placement of needles around the puncture site; and a suture knot pusher. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28717648000625 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 08717648000621 | GS1 |
Customer Contacts
- Phone
- +1(800)227-9902
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Store in a cool place (room temperature).