FDA UDI
In Commercial Distribution
🇺🇸 United States
Zepto Capsulotomy System
DI: B560E10000
·
Model: E1000
·
MYNOSYS CELLULAR DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Zepto Capsulotomy System
- Primary DI
- B560E10000
- Version / Model
- E1000
- Catalog Number
- E1000
- Company Name
- MYNOSYS CELLULAR DEVICES, INC.
- Labeler DUNS
- 827036927
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-19
- Public Version
- 3
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 99b82b15-3dd9-4726-aaec-e98ed0707f8c
Device Description
Zepto Fluid Isolator
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUL | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered | Ophthalmic | 886.4100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44681 | Electrosurgical handpiece, single-use | A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B560E10001 | HIBCC | Cellophane bag/carto | 10 | In Commercial Distribution | |
| Primary | B560E10000 | HIBCC |
Customer Contacts
- Phone
- 5108576296
- [email protected]
- Phone
- 5104153245
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry