Identity
- Trade Name
- Nucleus Sustainer FDA UDI
- Generic Name
- Ophthalmic surgical probe, reusable FDA UDI
- Model / Reference
- 37-0070 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00883475953640 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- Ophthalmic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic surgical probe, reusable
Nucleus Sustainer by Charmant Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical probe, reusable.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Titanium Nucleus Splitter — KATALYST SURGICAL, LLC · Class I
- Scleral Depressors — AURORA SURGICAL, LLC · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Charmant Inc.
Sources (1)
- FDA UDI a73eaabe-8e18-4110-a35a-3ca1606aedad 32 fields · synced Jun 1, 2026