FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ProtekSolo
DI: 00814112020463
·
Model: 5100-1422
·
CARDIACASSIST, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ProtekSolo
- Primary DI
- 00814112020463
- Version / Model
- 5100-1422
- Company Name
- CARDIACASSIST, INC.
- Labeler DUNS
- 948683941
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-22
- Public Version
- 6
- Public Version Date
- 2024-08-15
- Public Version Status
- Update
- Public Device Record Key
- 0b13a349-9ce2-4f90-9643-df2f760a6f2b
- Distribution End Date
- 2024-04-03
Device Description
Three 25 cm Dilators (14 Fr, 18 Fr, and 22 Fr)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | 870.1310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38128 | Vascular dilator, single-use | A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814112020463 | GS1 |
Customer Contacts
- Phone
- 4129637770
- [email protected]
- Phone
- 18003737421
- [email protected]