FDA UDI
In Commercial Distribution
🇺🇸 United States
RadiStop™
DI: 05414734050050
·
Model: C11177
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RadiStop™
- Primary DI
- 05414734050050
- Version / Model
- C11177
- Catalog Number
- C11177
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 149818952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-19
- Public Version
- 3
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- de449ba9-3dfc-4721-a7f3-272324e655ee
Device Description
Compression Assist Device
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
- Yes
- 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 |
|---|---|---|---|---|
| GAX | TOURNIQUET, NONPNEUMATIC | General, Plastic Surgery | 878.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58704 | Radial artery compression device | A device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15414734050057 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 05414734050050 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Do not use if package is damaged.