Identity
- Trade Name
- Oertli® FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, single-use FDA UDI
- Device Name
- PHACO TIP EXCELLERATOR 2. 30°; SLEEVE, TEST CHAMBER; FDA UDI
- Model / Reference
- VV806834 FDA UDI
- Description
- PHACO TIP EXCELLERATOR 2. 30°; SLEEVE, TEST CHAMBER; FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003908855 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Phacoemulsification system handpiece tip, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 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
Yes
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
Dimensions & Sizes
- Size
- Needle Gauge — 19 Gauge FDA UDI
Category: Phacoemulsification system handpiece tip, single-use
Oertli® by Oertli-Instrumente AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification system handpiece tip, single-use.
- LAMINAR — Johnson & Johnson Surgical Vision, Inc. · Class II
- CANNULA — MED LOGICS INC · Class IIa
- UNITY — Alcon Laboratories, Inc. · Class IIb
- Sterile Light Fibers — Vitreq B.V. · Class IIa
- UNITY — Alcon Laboratories, Inc. · Class IIb
- 2.8 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Constellation — Alcon Laboratories, Inc. · Class IIb
- AMO PHACO NEEDLE — Johnson & Johnson Surgical Vision, 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
- Oertli-Instrumente AG
Sources (1)
- FDA UDI 94fc61a0-c53f-4b12-85dc-58dda4e9f15a 35 fields · synced May 30, 2026