Identity
- Trade Name
- Screwdriver FDA UDI
- Generic Name
- Pacing/defibrillation lead setscrew FDA UDI
- Model / Reference
- ICD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08031527009230 FDA UDI
- FDA Product Code
- MRM FDA UDI
- GMDN Term
- Pacing/defibrillation lead setscrew FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pacing/defibrillation lead setscrew
Screwdriver by Microport Crm Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pacing/defibrillation lead setscrew.
- TW — BIOTRONIK SE & Co. KG · Class III
- Screwdriver — MICROPORT CRM SRL · Class III
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Microport Crm Srl
Sources (1)
- FDA UDI 626f7163-c9e7-4c07-85f4-301d08e3abbf 30 fields · synced May 30, 2026