Identity
- Trade Name
- Alcon FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- GRAVITY FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip FDA UDI
- Model / Reference
- 8065752217 FDA UDI
- Description
- GRAVITY FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657522170 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
- Angle — 45 degree FDA UDIOuter Diameter — 0.9 Millimeter FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Alcon by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
- 3 POLI-SAFE 60X45 C/ ADESIVO — Linea Sterile S.p.A. · Class I
- CustomEyes® — Beaver-Visitec International, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- LAPAROSCOPIC SLEEVE RESECTION PACK — Johnson & Johnson Medical GmbH · Class III
- KIT GINECOLOGIA LAPAROSCOPIA — Linea Sterile S.p.A. · Class I
- SET 273 Ambulant — BATIST Medical Productions s.r.o. · Class III
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · 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
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI a7a7234d-47f1-4508-8633-6e4a8c5404ca 35 fields · synced Jun 1, 2026