FDA UDI
In Commercial Distribution
🇺🇸 United States
Epsila EV™
DI: 00763000369743
·
Model: EAZ201
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Epsila EV™
- Primary DI
- 00763000369743
- Version / Model
- EAZ201
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-03
- Public Version
- 2
- Public Version Date
- 2025-05-28
- Public Version Status
- Update
- Public Device Record Key
- 6c57f666-0d84-455e-984e-c77a7b6455fb
Device Description
TOOL EAZ201 TUNNELING ZONE 2
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) | Unknown | 3 | |
| NVY | Permanent defibrillator electrodes | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60956 | Pacing/defibrillation lead tunneller | A sterile hand-held manual surgical instrument designed to create a tunnel (an artificial passageway) through subcutaneous tissue for the placement of an implantable extracardiac lead/electrode. It is a long, thin, semi-flexible rod with a rounded distal tip and a handle at the proximal end to allow the surgeon to push through body tissues; it may include an integrated sheath (e.g., split sheath) intended to assist lead placement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000369743 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P220012 | 000 |
| P220012 | 044 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -31 – 136 Degrees Fahrenheit