Identity
- Trade Name
- Capsule Polishing Curette FDA UDI
- Generic Name
- Ophthalmic curette, reusable FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840096200140 FDA UDI
- FDA Product Code
- FZS FDA UDI
- GMDN Term
- Ophthalmic curette, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Category: Ophthalmic curette, reusable
Capsule Polishing Curette by Katalyst Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic curette, reusable.
- S.C.A — SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Sklar® — Sklar Corporation · Class I
- Curette — Koros USA, Inc. · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Curette — Katena Products, Inc. · Class I
- Comfort Plus Curette — Koros USA, 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 |
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Manufacturer
- Manufacturer
- Katalyst Surgical, Llc
Sources (1)
- FDA UDI 2f3560e4-6604-466c-9f4e-0ee2a446f81e 32 fields · synced May 30, 2026