FDA UDI
Not in Commercial Distribution
🇺🇸 United States
STRADIS HEALTHCARE
DI: M7525250720
·
Model: 525-072
·
STRADIS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- STRADIS HEALTHCARE
- Primary DI
- M7525250720
- Version / Model
- 525-072
- Company Name
- STRADIS MEDICAL, LLC
- Labeler DUNS
- 174262477
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-21
- Public Version
- 3
- Public Version Date
- 2023-02-07
- Public Version Status
- Update
- Public Device Record Key
- 09e8e4c7-d6f1-4e10-a4bd-015a8cc51d4f
- Distribution End Date
- 2023-02-06
Device Description
5FR MICRO INTRODUCER KIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| OFL | Percutaneous Sheath Introducer Kit | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33961 | General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7525250720 | HIBCC |
Customer Contacts
- Phone
- 770-962-2425
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 45 | Centimeter | |
| Catheter Gauge | 5 | French |