Identity
- Trade Name
- Alcon, Infiniti, MicroSmooth, ABS FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- 0.9 mm 30° Kelman® Tapered ABS® Tip FDA UDI
- Model / Reference
- 8065750280 FDA UDI
- Description
- 0.9 mm 30° Kelman® Tapered ABS® Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657502806 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, 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
No
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
- Outer Diameter — 0.9 Millimeter FDA UDIAngle — 30 degree FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Alcon, Infiniti, MicroSmooth, ABS by Alcon Laboratories, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI 156082e7-5c0a-479f-9427-1bb931fbb094 35 fields · synced Jun 8, 2026