FDA UDI
In Commercial Distribution
🇺🇸 United States
Screwdriver
DI: 08031527009629
·
Model: ICV1204
·
MICROPORT CRM SRL
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Screwdriver
- Primary DI
- 08031527009629
- Version / Model
- ICV1204
- Catalog Number
- ICV1204
- Company Name
- MICROPORT CRM SRL
- Labeler DUNS
- 438860859
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-05
- Public Version
- 5
- Public Version Date
- 2023-06-27
- Public Version Status
- Update
- Public Device Record Key
- 864029ff-e6c3-443b-b014-fe8e6eb4f019
Device Description
MicroPort Screwdriver for active devices
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
- 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 |
|---|---|---|---|---|
| NVZ | Pulse generator, permanent, implantable | Unknown | 3 | |
| DXY | Implantable Pacemaker Pulse-Generator | Cardiovascular | 870.3610 | 3 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46223 | Pacing/defibrillation lead setscrew | A sterile device designed to secure the attached pacing lead terminal(s) in the header connector (connection socket) of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure. It is typically made of high-grade stainless steel or titanium (Ti). The device is typically available in a set of graduated sizes. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08031527009629 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P950029 | 127 |