Identity
- Trade Name
- Zepto Capsulotomy System FDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- Zepto Handpiece FDA UDI
- Model / Reference
- Z1000 FDA UDI
- Description
- Zepto Handpiece FDA UDI
Identifiers
- Catalog Number
- Z1000 FDA UDI
- Primary DI / UDI-DI
- B560Z10000 FDA UDI
- FDA Product Code
- PUL FDA UDI
- GMDN Term
- Electrosurgical handpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Electrosurgical handpiece, single-use
Zepto Capsulotomy System by Mynosys Cellular Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical handpiece, single-use.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ES Pencil Rocker;2.6" Blade Tip; Stainless Steel; Blue Insulation — XODUS MEDICAL, INC. · Class II
- ES Pencil Rocker 2.75" Blade Electrode Stainless Steel — XODUS MEDICAL, INC. · Class II
- J-Plasma® — Apyx Medical Corporation · Class II
- ES Pencil Button;; 2.75" Needle Tip; Blue PTFE; Blue Insulation — XODUS MEDICAL, INC. · Class II
- BOVIE — BOVIE MEDICAL CORPORATION · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Plasma IQ Docking Station — NEAUVIA NORTH AMERICA, INC · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mynosys Cellular Devices, Inc.
Sources (1)
- FDA UDI 656f84ea-9f91-4242-b2a0-7e8f428bf28b 36 fields · synced May 31, 2026