Identity
- Trade Name
- Titanium Henderson Degree Gauge FDA UDI
- Generic Name
- Ophthalmic angular gauge, reusable FDA UDI
- Model / Reference
- 8505 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840096200638 FDA UDI
- FDA Product Code
- HMR FDA UDI
- GMDN Term
- Ophthalmic angular gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4570 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
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
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
MR Conditional FDA UDI
Category: Ophthalmic angular gauge, reusable
Titanium Henderson Degree Gauge by Katalyst Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Katalyst Surgical, Llc
Sources (1)
- FDA UDI 2784b265-09e7-40a1-a3ad-cfd0b393fdcb 32 fields · synced May 30, 2026