Identity
- Trade Name
- Procedure Pack FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Procedure Pack LASIK Ø 9.0mm FDA UDI
- Model / Reference
- 9.0 LASIK FDA UDI
- Description
- Procedure Pack LASIK Ø 9.0mm FDA UDI
Identifiers
- Catalog Number
- 510.700.101 FDA UDI
- Primary DI / UDI-DI
- 07640167750498 FDA UDI
- 510(k) Number
- K112154 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 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
- Lumen/Inner Diameter — 9.0 Millimeter FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Procedure Pack by Sie Ltd Surgical Instrument Engineering — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112154 also covers:
- FEMTO LDVᵀᴹ Intershields — Sie Ltd Surgical Instrument Engineering
- FEMTO LDVᵀᴹ Intershields — Sie Ltd Surgical Instrument Engineering
- FEMTO LDVᵀᴹ Intershields — Sie Ltd Surgical Instrument Engineering
- FEMTO LDVᵀᴹ Intershields — Sie Ltd Surgical Instrument Engineering
- FEMTO LDVᵀᴹ Intershields — Sie Ltd Surgical Instrument Engineering
- FEMTO LDVᵀᴹ Intershields — Sie Ltd Surgical Instrument Engineering
- FEMTO LDVᵀᴹ Intershields — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
- Procedure Pack — Sie Ltd Surgical Instrument Engineering
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
- Sie Ltd Surgical Instrument Engineering
Sources (1)
- FDA UDI 6b2cc5c8-b24f-44c2-9b96-cc1861f143f2 37 fields · synced May 30, 2026